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HEALTHCARE

LIFE SCIENCES
REVIEW

&

PHARMACEUTICALS:
SHAKING UP THE SYSTEM
PAGE 21

A TIMELINE OF REFORMS
PAGE 8

CARVING OUT A MEDICAL


DEVICE MARKET
REDEFINING
CRISIS
PAGE
56

MANAGEMENT
PAGE 14

INTERVIEW
WITH:
CONVERGENCE
IN ACTION:
JOAQUIM
CUNHA,
CASE STUDY: SILANES
FOCUS ON DIABETES
BIAL: THE PORTUGUESE
EXECUTIVE DIRECTOR,
PAGE 70
PAGE 82
HIGH FLYER
PAGE 16

HEALTH CLUSTER
PORTUGAL PAGE30

MEXICO 2013
COFEPRIS Revamped
Mikel Arriola, the man who changed an institution and an industry PAGE 18

CONTINUE TO INVEST IN PORTUGAL


published in association with

HEITOR COSTA, EXECUTIVE DIRECTOR, APIFARMA. PAGE 28

PORTUGAL
2013

April 2014

PTCOR0130_Fev2014

Almirall is a pharmaceutical company commited to health that bases


its strategy on innovation and international growth. Headquartered
in Barcelona (Spain), Almirall researches, develops, manufactures and
markets propietary R&D and third party drugs for the purpose of improving peoples health and well-being.

PORTUGAL APRIL 2014

Acknowledgements
Pharmaboardroom would like to thank all
individuals, institutions and companies involved
in producing this report.
Special thanks go to :
Manuel Teixeira, Secretary of State for
Health, Ministry of Health of Portugal,
Pedro Gonalves, Secretary of State for
Innovation, Investment and
Competitiveness,
Heitor Costa, Executive Director of
APIFARMA,
Joaquim Cunha, Executive Director of
Health Cluster Portugal
and
Nuno Arantes-Oliveira, President of P-BIO
for their continued support and assistance.
We hope you enjoy reading this report as
much as we did creating it!
PORTUGAL APRIL 2014

CONTENTS

6
7
8
10
12
14
14
15
16
17
18
19
20

PREPARING THE NEW PORTUGAL


WHAT WENT WRONG
A TIMELINE OF REFORMS
TAKING THE HIT
GENERICS: HEADROOM FOR INNOVATION?
REDEFINING CRISIS MANAGEMENT
NATIONAL PRIDE
BIG PLAYERS, BIG RESPONSIBILITY
BIAL: THE PORTUGUESE HIGH FLYER
BUILDLING AN AFFILIATE FROM AN AFFILIATE
CAN SCIENCE = PROFIT?
ORPHAN DRUGS AND AUSTERITY
BIOTECH: SMALL BUT GROWING

INTERVIEWS

24 
Interview with: Pedro Gonalves, Secretary of State for Innovation, Investment and
Competitiveness - Ministry of Economy of Portugal
Interview with: Manuel Teixeira, Secetary of State for Health 26 
Ministry of Health of Portugal
Interview with: Dr. Heitor Costa, Executive Director - Apifarma
28 

30 
Interview with: Joaquim Cunha, Executive Director - Health Cluster Portugal
32 
Interview with: Abel Vizeu Fernandes, Country Director - Kedrion Portugal
34 
Interview with: Alberto Inez, General Manager - Sanofi Portugal
36 
Interview with: David Malta and Daniela Couto, Co-Founders - Cell2B
38 
Interview with: Eduardo Pinto Leite, Director General - GSK Portugal
40 
Interview with: Francisco Velez, Director General - toLife
42 
Interview with: Joo Lobo Antunes, Founder - Institute of Molecular Medicine (IMM)
44 
Interview with: Jos Albino Mendes, General Manager - Servier Portugal
46 
Interview with: Marta Ferreira, General Manager - Inovapotek
48 
Interview with: Miguel Lopes da Cunha, CEO - FAPOMED SA
50 
Interview with: Pedro Merlini, Country Manager - Aurobindo Portugal
This report was prepared by Pharmaboardroom.com
Editorial Coordinator: Cameron Rochette

Project Coordinator: Emilie Laumond

Project Assistant: Olga Palaga

Project Publisher: Julie Avena

Graphic Assistance: Omar Rahli,Nisha Albuquerque


Copyright
All rights reserved. No part of this publication maybe reproduced in any form or by any means, whether electronic, mechanical or otherwise including
photocopying, recording or any information storage or retrieval system without prior written consent of Focus Reports.
While every attempt is made to ensure the accuracy of the information contained in this report, neither Focus Reports nor the authors accept any
liabilities
for errors APRIL
and omissions.
PORTUGAL
2014Opinions expressed in this report are not necessarily those of the authors.

PORTUGAL APRIL 2014

PORTUGAL:

Photo credits: Olga Palaga

Preparing the New Portugal

hen PharmaBoardroom came to Portugal in 2007, price


cuts, payment delays and changes to the health system
with each successive government were but the first indications for the pharmaceutical sector that troubled times
were ahead: four decades of political and financial mismanagement had resulted in Portugals economic stagnation. When the
country requested a financial bailout by the IMF in spring 2011,
the country quickly came round to face reality. Adaptation was
paramount to the recovery of this economically ravaged nation,
and government and industry quickly sought to find new solutions to the crisis. In 2014, renewed economic growth and a willingness by all stakeholders to work together will be the keystones
to preparing Portugals revitalization.
PORTUGAL APRIL 2014

This sponsored supplement


was produced by Focus Reports.
Editorial Coordinator: Cameron Rochette
Project Coordinator: Emilie Laumond
Project Assistant: Olga Palaga
Project Publisher: Julie Avena
Graphic Assistance: Omar Rahli,
Nisha Albuquerque
For exclusive interviews and more info, please
log onto www.pharmaboardroom.com
or write to contact@focusreports.net

of Janssen Portugal. ParticiThen-White House Chief


pating in APIFARMA is also
of Staff Rahm Emanuel comcritical; we believe in the promented in 2009, You never let
tocol, and Janssen believes this
a serious crisis go to wasteits
is an important tool in terms
an opportunity to do things you
of placing everyone together
think you could not do before.
to determine a solution for the
This mantra parallels the mindgovernment, industry and ultisets of many in Portugals pharmately the patients. This promaceutical industry today. Af- From left: Heitor Costa, Executive Director, APIFARMA; Eurico
tocol was also the first of its
ter serious downturns in the last Castro Alves, President, INFARMED; Manuel Teixeira, Secretary of
State for Health
kind in Portugal; no other infew years, the country is poised
dustry has given money back
for restoration. While many beto the government. Many companies
ing on healthcare to be limited to only
lieve that returning to the environment in
had to work hard internally to make this
one percent of GDP, one of the lowest in
the years preceding the crisis is not likely,
protocol work for two consecutive years;
all of Europe. As such, the pharmaceuthere is immense hope for a return to rebut it represents a real partnership.
tical industry created a memorandum
spectable market levels.
APIFARMA maintains a stance of
of understanding (MoU) that stipulated
dialogue, which always prevails, says
the industry contribute EUR 600 milWhat Went Wrong?
Eduardo Pinto Leite, vice president of
lion (USD 780 million) in savings back
APIFARMA and director general of
to Portugals healthcare system between
Portugals austerity measures for healthGSK Portugal. The industry is here be2011 and 2012. This was followed up
care are similar to those across Europe,
cause it has been given a license to opwith a similar MoU for 2012-2013.
but are more extreme because of the
erate for society. Although conditions
This agreement was critical to encountrys bailout. As health plays a maare rough, particularly with lack of debt
suring stability in Portugal, especially
jor role in Portugals budget allocation,
payment and slowness of innovation enfor innovative companies. We try to
the pharmaceutical industry has been
try, the Ministry of Health knows the inwork closely with Portugals regulatory
targeted as an area for cutting costs.
dustry is here to stay. With that in mind,
authority INFARMED and the MinisImposing the lowest prices in Europe
we have always supported dialogue.
try of Health to find best ways to bring
based on reference countries, creating rePartnership between the health sysinnovation to Portuguese patients, restrictive access measures, and refusing to
tem and the pharmaceutical industry
marks Gisella Dante, general manager
compensate new medicines are all easier
than merging hospitals
or changing policy at
Impact of austerity measures
the level of the MinisThe market value returns to levels from 2002
try, says Heitor Costa,
(USD 1.06 billion)
BN
executive director of
28%
Market Value
2,791 2,821 2,792
Portugals pharmaceu2,667
2,640
Market Growth
24% 812M
2.5
tical association API2,541
28,8%
2,413
2,395
20%
FARMA. He believes
2,206
2,158
16%
that it is easier for the
2.0
2,130
2,061 2,009
1,976
health system to make
12%
9,4%
1,819
7,8%
cuts in the area of phar8%
5,3%
5,7%
1.5 8,4% 8,6%
3,9%
3,6%
maceuticals, the major4%
1,1%
ity of which are reim0%
2,5%
bursed by the countrys
1.0
1,0%
4%
government, than in
4,5%
4,5%
8%
other areas. The troika
0.5
9,9%
10,2%
12%
of the Central Europe16%
an Bank, International
Monetary Fund (IMF),
20%
0.0
and European Com2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
mission have set a goal
Source: IMS historical data
*2013; 2014 projection based in accumulated November data
for government spendS2 FOCUS REPORTS

april 2014

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A TIMELINE OF REFORMS

2007

2008
2009

2010

2012

6% Reduction Ordinance n 30-B/2007

(Jan.)

System of price caps DL.65/2007

(May)

5%, 9% or 12% Reduction applied to generic drugs with a market share of: 50% < Q < 60%, 60% < Q < 70% e Q
> 70% Ordinance n 300-A/2007

(May)

Review under the new pricing methodology DL.65/2007 and Ordinance n 300-A/2007

(Apr.)

30% Price cut for generic drugs maximum prices Ordinance n 1016-A/2008

(Oct.)

Review under the new pricing methodology DL.65/2007 and Ordinance n 300-A/2007

(Apr.)

Reduction resulting from the transfer of margins for pharmacies and wholesalers at 3.85 factor - DL.48/2010

(Jun.)

7% Average price reduction on drugs, in accordance with the pricing methodology review - Ordinance n 312A/2010

(Jul.)

20-35% Price cut for some generic medicinal products

(Aug.)

6% Mandatory Discount in Retail Price for all reimbursed medicines - Ordinance n 1041-A/2010

(Oct.)

7.5% Price cut for biological medicines Despatch n 18419/2010

(Dec.)

New pricing methodology with a new set of reference countries (Spain, Slovenia and Italy), new marketing margins
for wholesalers and pharmacies, and new generic prices (50% below the RRP of the reference product, or 25% if
the wholesale price is less than 10)

(Jan.)

Downward prices review for branded drugs 1/April by the application of the new reference countries (Spain,
Slovenia and Italy) - DL.112/2011

(Dec.)

Source: Price Legislation DL - Decree Law

PORTUGAL APRIL 2014

DO
UNI

ADE H MAIS DE
S PELA S
1 00

Ciclum Farma Unipessoal, Lda.


Quinta da Fonte, Edifcio D. Amlia
Piso 1, Ala B - 2770-229 Pao de Arcos
Tel: 21 120 98 70 Fax: 21 441 07 54
www.ciclumstada.pt

april 2014

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OS

Ciclum/XX/Jan14 3300440

must be more than noble intentions and


enthusiastic words, notes Secretary of
State for Health Manuel Teixeira. Despite specific missions and frequent divergent approaches, health system activities
and pharmaceutical interests have symbiotic connections. Bearing this in mind we
are open to discuss balanced and affordable partnerships that give patients equal
access to valuable treatments.
The industrys protocol to provide
savings for the healthcare system over
the last two years has seriously affected
the introduction of new drugs into Portugal. For the last two and a half years,
an extremely limited number of medications have been
accepted for reimbursement. Portugal has been part of
Europe for a long
time, but it feels
like the country is
leaving Europe because of this lack
Eduardo Pinto Leite, of access to new
General Manager,
medicines to fulGSK Portugal
fill unmet medical

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needs, continues APIFARMAs Costa. Sustainability is one of the main
preoccupations of all companies here
and elsewhere in Europe. The industry
should share risks in that sustainability
while still maintaining access to innovation; the state currently designs the
market for each company, which creates uneven competitiveness and is generally incomprehensible.
The government has very demanding concrete targets to achieve, of
which the industry is aware, says Nelson Ambrogio, managing director of
Bayer Portugal. There is a collaborative spirit between government and the
industry, and there are clear challenges
for issues like innovation approval.
The period between marketing authorization and access to medicine in Portugal is almost 500 days. This figure
is more than one year for approval in
many other European countries.

Public Expenditure on pharmaceuticals per capita


both retail and hospital markets
600
500
400
300
200
100
0

2
2
1
1
2
1
e in
s ia
y
ia
d
1 ia 2 3
D
ce land man ranc Spa blic ium land ustr urg EC Italy lan 01 ven 01 01 ton
e
o
n l 2 lo l 2 l 2 Es
O
u
r
g
r
F
e re e
i
l
A
b
r
p
e
F
e
G I G
m
ga S uga uga
Re B eth
xe
tu
N
rt rt
ak
or
Lu
v
P
Po Po
o
l
S

Source: OECD health data


1. Cannot be separated and includes medical non-durables. 2. Prescribed medicines only.
Euro zone countries BCDE Indicators 2009 (or nearest year) Portugal 2010,2011 Infarmed Reports Ambulatory;
2013 Target MOU for 2013

tecnifar.pt

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Veronique
France
Mylan Senior Plant Director

Part of this issue


revolves around the
complex regulatory
system of Portugal,
which pharmaceutical companies often
struggle to comprehend.
Eurico
Castro Alves, presiFrom left: Robin Turner, General Manager,
Roche Portugal; Rui Carrington, CEO, OCP dent of Portuguese
Portugal
regulatory authority INFARMED, is making efforts to help streamline many
of INFARMEDs processes, such as the implementation of
an autonomous and integrated national system for the evaluation of health technologies. This system will be the basis for
the decision on public funding for medicines and medical devices according to their cost-effectiveness, says Castro Alves.
The goal is to ensure equity in national access to medicines
and medical devices, making available better suited treatments
to the clinical situation of each patient, and correlating them
to the resources of the national health system. Additionally,
INFARMED also played a key role in the creation of the Forum of Portuguese Speaking Medicines Agencies (FARMED).
Through this project and through mutual cooperation, comments Castro Alves, the objective is to move towards a more
convergent regulatory framework, strengthening national capacities to promote and ensure access and rational use of quality, effective and safe medicines, contribute to the sustainable
development of the sector and the respective health systems,
and promote the elimination of barriers to such development.

I can

taking the hit


Between Portugals two main distribution channels of hospitals
and pharmacies, hospitals have suffered in particular. As the
pharmaceutical industrys largest customer, it has been critical for government to work with pharmaceutical companies to
find solutions. Robin Turner, general manager of Roche Portugal, likens the relationship of the industry with the market to a
marriage: Sometimes they struggle because of money. This
struggle has been quite severe in some cases; public hospitals in
Portugal owe more than EUR 1 billion (USD 1.3 billion) in debt
to the pharmaceutical industry. As the largest hospital-based
pharmaceutical company in Portugal, Roche was owed a colossal amount. As a consequently, Roche reluctantly introduced
a new commercial policy for the 25 percent of hospitals that
had the longest outstanding payments, recalls Turner. These
were hospitals that owed us between 500 and 1500 days. We insisted on cash payment until the historic debts were paid back.
It was a resounding message to the marketplace to address the
issue and promulgate change. Happily today, all historic debt
has been paid back to Roche. We therefore have a clean slate

feel good about being a part


of a single-minded team of
employees, all equally responsible
for ensuring the quality of our
the world they are made.
I can

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MKT 88-12-13 | *We share the taste for life

ANOS

and progressively increase


and the payment discipline
the fixed part of it to cover
of hospitals is at a stable and
the major part of operational
acceptable level.
costs. This is the best way to
Pharmacies have also endured
ensure compliance with GDP
their struggles as well. In 2008,
and the Statute of Medicines,
the ambulatory market was valand to preserve the model.
ued at EUR 2.8 billion (USD 3.6
Transparency
mechabillion), while today its market
nisms are needed across the
size is the same as it was in 2002, From left: Gisella E. Dante, General Manager, Janssen Portugal;
representing a EUR 812 million Nelson Ambrogio, Managing Director, Bayer Portugal; Rui Ferreira Dos entire supply chain, conSantos, Country Manager, Almirall Portugal
cludes Carrington. Com(USD 1.06 billion) loss, or roughpensation measures to support operaproblems across the supply chain as a rely 29 percent. Rui Carrington, CEO of lotional costs across the supply chain can
sult of these factors, Carrington suggests
cal pharmaceutical distributor OCP Porprevent and manage supply shortages.
increased collaboration between distributugal, indicates that the model pharmacy
Transparency and reliable information
tors and pharmacies as well as increased
shop as it is known today and patient acabout quantities available from manufacproductivity among all players. Reduccessibility to drugs have been affected as a
turers can also make a difference. Defining the actual level of credit from wholeconsequence. It is possible that punctual
ing a life-saving list of medicines that all
salers to pharmacies would be a start.
short-term market supply problems arise
players should commit to, granting PubThis would require banks to provide
because of economic conditions or lack
lic Service Obligations (PSO) would also
credit lines that allow both to restructure
of financial capacity to support pharmahelp. Transparency and exchange of relitheir debts, recommends Carrington.
ceutical distribution, shortage of bank
able information about real needs, availWe need to at least maintain the current
credit and continuing reduction in market
ability, quantities and deliveries should be
margins of pharmaceutical distribution
value, says Carrington. In order to fix
the guiding principle.
In response to the crisis, the Portuguese affiliate of Spanish pharmaceutical group Almirall took a courageous
decision to stop all commercial activity
at the beginning of 2011 in response to
a mature portfolio and strong erosion of
sales. Since 2011 we do not have any
field force promoting products, explains
Rui Ferreira Santos, country manager of
Almirall Portugal. My small team here is
focused on the access of new products we
were expecting from our own R&D and
licensing agreements. Thus, in response
to the crisis, rather than work on mature
products, we prepared the market and
ground to bring new products.
Ensuring a strong performance in clinical trials is also important for Portugal
to recover. The strategic value of clinical
research for Portugal is now being recognized by the Portuguese government and
by INFARMED, says Janssens Gisella
Dante. Recently, some important initiatives have been put in place such as the
launch of the National Platform for Clinical Research and INFARMED and the
toLife Produtos Farmacuticos, S.A. | Avenida do Forte, 3 | Edifcio Sucia III | Piso 1 | 2794-093 Carnaxide | Portugal | T +351 214 342 700
Portuguese Central Ethics Committee are
|
|
|
|
|
F +351 214 342 709 E-mail tolife.geral@tolife.pt www.tolife.pt NIPC 506 698 599 C.R.C. Cascais, sob n 16 316 Capital Social 3 436 740,00 euros
assuming a leading role within the EMA

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Voluntary Harmonization Procedure. On


the other hand, there are a growing number of hospitals setting up clinical research
units in order to increase their effectiveness in this field. In 2013, for the first time
in years there was an inversion in the negative trend regarding the number of clinical trials approved annually. The signs are
encouraging and Janssen has been fully
engaged in this process.
Clinical trials are a way of ensuring
early access to innovation, obtaining clinical expertise and are one way to attract investment to the country, says Amgen Portugal country manager Ramn Palou de
Comasema. As a country, Portugal has
significant potential to improve in terms
of implementation of clinical trials. The
expertise of clinicians in hospitals here is
unprecedented. However, we need to improve processes. The most important part
of this is to ensure that in the future, companies will continue to invest in Portugal.

Between 2008 and 2013, price cuts resulted in a 75 percent decrease in generic
prices, resulting in significantly lower
prices for generics compared to Portugals
new reference pricing countries of Italy,
Spain and Slovakia. This also makes it
difficult for generic companies to justify
selling in a country where profits would
be so low. By contrast, originator prices

From left: Paulo Lilaia, CEO, Generis;


Francisco Velez, Director General, toLife

have only decreased 6.1 percent since


2009, creating an unsustainable gap between originators and generics.
According to Francisco Velez, director
general of generics player toLife, innovagenerics: headroom
tive companies benefited for many years
for innovation?
because Portugal only had process patents,
and the balance of product patent protecIn PharmaBoardrooms first coverage
tion changed when generics were introof Portugal in 2007, generics repreduced in Portugal. The time between the
sented 16 percent of the pharmaceutiend of a process patent and the beginning
cal market, a tremendous feat considerof a product patents start on
ing laws for generics had only
the market is too long and genbeen implemented a few years
erates confusion, which leads to
before. Today, generics repredoubts about the market. Until
sent nearly 40 percent of the
one and a half years ago, toLife,
market in count units, and acwhich was acquired by Catalan
cording to the MoU, the aim is
pharmaceutical group Esteve in
to increase this to 60 percent
2007, simply had preliminary
by the end of 2014.
injections of registered prodUsing generics as a means of
ucts in INFARMED. If any incost-cutting for a fragile health Moiss Apura,
General Manager,
novative company was aware of
budget seems like an easy go- Ciclum Stada
such product registration, that
to option for Portuguese health
company could stop the approval program
authorities. Portugal has budget conthrough an administrative court. Such
straints, and can only spend around EUR
courts are not the right place to decide on
1.7 billion (USD 2.2 billion) for medicines
patents. I had products approved in 2007
every year, says Paulo Lilaia, president of
and they have just hit the market this year
Portugals generic association Apogen and
because they were blocked by the court,
CEO of local flagship generics company
sometimes with no reason. We lost huge
Generis. If we want to be able to buy inmarket opportunities, since otherwise we
novative therapeutics that add value, we
would be first place in the market.
must save money somewhere.
PORTUGAL APRIL 2014

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The generic medicines business
model was focused on high prices and
the commercial terms you could offer to pharmacies in particular, states
Mylan Portugal general manager Joo
Madeira. Of course, when you do not
have the market developed to the point
of pharmacy-based decisions (which you
would expect in a substitution market), Joo Madeira,
and when you start adopting strategies General Manager,
Mylan Portugal
and tactics that do not correlate with
the profile of that market, you will fail.
Focusing business on pricing and commercial strategies
alone, without creating the landscape to de-stigmatize generic medicines and increase its understanding by physicians
and patients is dangerous. Generic medicines used to be under a branded prescription-based business: physicians prescribed, drugs were shipped to pharmacies with a script, and
pharmacies would typically dispense whatever was in that
script, continues Madeira. That definitely did not help to
build the generic medicines marketplace in Portugal, and did
not allow for a proper understanding of the value of having a
developed generic medicines market in Portugal nor the need
for the authorities to leverage this market.

Lagoas Park in Oeiras, where many multinational pharmaceutical


companies are based in Portugal

The problem is that many stakeholders are involved in the


decision-making process, comments Moiss Apura, general
manager of generics business Ciclum Farma, which is owned
by Stada Group. Furthermore, pharmacists have lost so much
profit in the last three years as they are remunerated through a
percentage, so they prefer to sell originators over generics. Doctors lose the power to follow patients due to mandatory INN
prescription, especially since the brand dispensed at pharmacies
may change every month, complicating patients compliance.
That is why doctors prefer to prescribe originators. If the law

At Novartis, we want to discover, develop and provide


high-quality healthcare solutions to address the evolving
needs of patients and societies worldwide. We believe
that our diverse healthcare portfolio, our dedication to
innovation, and our responsible approach will enable us
to fulfill our mission to care and to cure.

NOV88/11/2013

For Novartis every day counts to deliver the right


treatment, for the right patient at the right time.

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Redefining crisis management


During the throes of Portugals economic crisis, Servier Portugal actually
created an international center for research that conducts several studies across Portugal for old and new
products. This center was created as
a symbol and a demonstration to doctors, authorities and internal collaborators that the company is truly investing
in Portugal, and is here to stay not just
to sell medicines but to also be a strategic partner. (Jos Albino Mendes,
general manager, Servier Portugal)
As a company that operates in very
specific markets, the first challenge
I encountered was to provide a more
global personality to the company,
and to make it more visible in the market and to stakeholders, local industry
and the Ministry of Health. The internal implementation of governance
boards that were not available at that
time was also a priority. By developing such boards, as well as functions,
job descriptions, and communication
flow, these simple aspects assisted in
the development and motivation of the
companys employees. (Nuno Brs,
general manager, LEO Farmacuticos
Portugal)

Jos Albino
Mendes, General
Manager, Servier
Portugal

Nuno Brs, General


Manager, LEO
Farmacuticos
Portugal

changed so that doctors could manage what is best for a patient


and follow the prescription and the margin to pharmacy is settled by fixed value instead of percentage, perhaps generics would
be prescribed more frequently.
Furthermore, according to Aurobindo Portugal country
manager Pedro Merlini, clear timeline definitions also need
to be established in Portugal. Companies need to know
exactly when an originator is launched, registered, when
changes are made to its indication, and when its patent protection ends. Without that clarification, a fair market is almost impossible, he notes.

national pride
While multinational pharmaceutical companies have been
forced to make the necessary adjustments to maintain their
presence in Portugal, national pharmaceutical companies in
Portugal have a different story. Despite the country lacking any

I had to change the way BMS relates with authorities. It used to be


a spot type of relationship, in which
a reimbursement or issue was discussed with the authorities. It is a
model that no longer works for the
entire industry, and I strongly believe that you need to have a different way of interacting with stakeholders. You need to really think Valentino Confalone,
General Manager,
about collaboration of partnership; BMS Portugal
what projects or elements are critical for them so that we can work together towards common goals. (Valentino Confalone, general manager,
BMS Portugal)
Bene operationally launched the Portuguese affiliate in 2010, when Portugals pharmaceutical industry was experiencing its worst year ever, followed
by two more years of even worse performance. In spite of these issues and
some publics skepticism towards our
optimist attitude, Bene has enjoyed
continual success in Portugal because
of the companys product reliability. Frank Tischler,
Managing Director,
Ben-u-ron, our main brand, has been Bene Farmacutica
the brand of confidence for several
years in a row because of our commitment to the people
through confidence, trust and quality. (Frank Tischler, Managing Director, Bene Farmacutica)
big pharma players, many of the midsized companies in Portugal have continued to thrive despite the national crisis by
looking at new outlets for growth.
According to Antnio Donato, vice
president of Tecnimede Group, clusterbased strategies would be useful for the
Portuguese health ecosystem. Organizations must focus on building an idenPedro Merlini,
Country Manager,
tity for a cluster, enhancing innovation
Aurobindo Portugal
though joint R&D projects, as well as
focusing on business development, exports, joint acquisitions
and international cooperation, he says.
As a result of local economic crises the issue of internationalization is becoming more and more important
for Portuguese companies, remarks Donato. The pharmaceutical market is heavily regulated, and differences
in regulatory systems typically lead to restrictions on the

CR Portugal Ad-OCP Portugal QP_


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Big players, big responsibility


With all its divisions combined, Novartis is the biggest player in the Portuguese market. In 2013, the
company invested EUR 4.8 million (USD 6.2 million) in clinical trials, and between 2009 and 2013
saw a 70 percent increase in R&D. This year, the
affiliate plans to launch nine new clinical trials.
Cristina Campos,

this country, doubled in size and scale compared


to a few years ago. I believe we can still do much
more if the government can ensure some stability and simplified processes. This will allow the
subsidiary to be seen as a reference for other
countries and to make Portugal a more attractive country for clinical trials.

Cristina Campos, CPO Head & Country President, CPO Head and
Country President,
Novartis Portugal answers our questions:

Is there a burden of responsibility in committing to the Portuguese population as the biggest player in the market?
With all five Divisions, Novartis serves more than one million
patients and consumers in Portugal. This is a huge opportunity, and our aspiration is to be seen as the most respected
and trustful player in the sector. From quality and compliance
standards to the excellence of the delivered programs in the
market, there is a huge burden of responsibility. Given our
big scope and diversified portfolio and pipeline, Novartis Portugal has an obligation to be a role model in positioning the
pharmaceutical industry as a respected and collaborative
player in the Portuguese economy and society.

Novartis Portugal

What is the importance of clinical research for


Novartis Portugal?
Novartis Portugal is building capabilities internally by bringing the right people into the organization as well as upgrading the current skills of our workforce, allowing us to
have the best medical team in the industry. By overcoming
process barriers currently in the market, we can speed up
the approval clinical trials in Portugal and ensure Portugals attractiveness for clinical research. Novartis has 20
ongoing clinical trials, enrolling 400 patients in Portugal.
We are therefore one of the biggest sponsors of trials in

LOOKING TO THE

FUTURE.

Focusing on Quality and Technological Innovation,


we develop and commercialize a wide range of
Pharmaceutical Products, offering a portfolio of
more than 80 Products for Out Licensing.
Contact us at: gtm@tecnimede.pt
Tecnimede Group
Rua da Tapada Grande, 2 - Abrunheira - 2710-089 Sintra - PORTUGAL
Tel: +351 21 041 41 00 - Fax: +351 21 941 08 39
www.tecnimede.com

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Bial: The Portuguese high flyer


Founded in 1924
R&D unit established in 1993
Products are distributed in 52
countries worldwide
Therapeutic areas include musculoskeletal, CNS, cardiovascular, antibiotics, respiratory and
immunotherapy
Largest national company in the
Antnio Portela,
Portuguese market
CEO, Bial

Bial made headlines in October 2013 when their


antiepileptic drug Zebinix (marketed in the United
States as Aptiom) was approved by the Food and
Drug Administration for commercialization in the US,
the first ever Portuguese-developed drug to do so.
Already commercialized in Europe since 2009, Bial
has invested EUR 300 million (USD 390 million) and
the last 13 years in developing Aptiom. It was a
huge challenge for the team, which had no experience in developing drugs and submitting them to
regulatory authorities, remarks Bials CEO Antnio
Portela. This project helped transform Bial from
a local to an international company. For a familyowned company, Bials R&D and internationalization
investments are enormous. Portela attributes this
to the companys ability to think in the long-term:
We hope that the revenue from the development
of Aptiom will allow us to invest in continuing to develop our pipeline and our presence in international
markets.

From left: Antnio Chaves Costa, CEO, Tecnifar; Antnio Donato,


Vice President, Tecnimede Group; Pedro Ferraz da Costa,
Chairman of the Board, Iberfar

percent of its sales from the in-licensing of drugs from multinational companies, relying on its flexibility to adapt to
the needs of each individual partner. Antnio Chaves Costa,
CEO of Tecnifar, says the company aspires for a diversification of partnerships to avoid being dependent on a specific
franchise from one partner. Whenever an opportunity arises
to complement the in-licensing business, the company looks
for specific brands or products available for acquisition.
Between 2010 and today, Tecnifar diversified its risk by
moving beyond pharmaceuticals, specifically beyond prescription medication, continues Costa. The company recently

(1924)

Marketing

(1951)
Manufacturing

(1997)
Pharmalogistics

Experience builds quality


Bials facilities in So Mamede do Coronado

registration of medicines or establishment of new companies, which significantly impacts entry in some markets.
Regulatory challenges are economic in nature, and are a
consequence of issues like barriers to trade and internationalization. As such, cooperation and discussion with
INFARMED and other competent authorities are crucial to
the evaluation and definition of how Portuguese companies
can enter foreign markets.
Diversification is also critical for many companies. As
an example, local player Tecnifar accumulates roughly 75

Rua Consiglieri Pedroso, 123, Queluz de Baixo,


2734-501 Barcarena, Portugal EU
Phone: +351 21 434 81 00, Fax: +351 21 434 81 01
Email: geral@iberfar.pt

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developed competencies in diagnostic
imaging services, including cardiology
and gastroenterology imaging, and the
OTC, nutraceutical and medical device
areas. Tecnifar has also partnered with
local biotech startup Technophage for
the last six years to strengthen R&D.
We finance the investigation, contribute
with project management and regulatory Hernni Srio,
affairs, while they provide the brains and General Manager,
Fresenius Kabi
investigators for a project in the bacterio- Portugal
phage area. This commitment to R&D is
a pillar of Tecnifar and we cannot present ourselves solely as
a commercial company with a sales force, even when talking
with potential partners.
While the pipelines of pharmaceutical companies today are quite complicated due to loss of patents, opportunities arise for businesses like Tecnifar to partner with
those companies that had to reduce their presence here,
concludes Costa. Our company has been in Portugal for
many years; we know all the stakeholders and the market
well enough to partner with a company with no budget for
their continued growth.

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Building Blocks
Similarly, manufacturing may also present opportunities for
continued growth, particularly given the low cost of production
and high quality in Portugal. Despite a shrink in the manufacturing industry, the possibility for a comeback is more real due to
government initiatives designed to relax labor laws and reindustrialize Portugal.
Every multinational pharmaceutical company with production capacity has abandoned their facilities in Portugal over the

Building an affiliate from an affiliate


Jaba Recordati was formed in
2006 through the acquisition of local pharmaceutical company Jaba
by Italian multinational Recordati.
The company is primarily focused
on ambulatory products in the areas of cardiovascular, urology and
pain. Jaba Recordatis general
manager Nelson Pires has worked
Nelson Pires,
hard to grow the company since General Manager,
he arrived four years ago.
Jaba Recordati
Most top companies are focused in the hospital business, and their margins
come from this area, says Pires. Therefore, there
is a big opportunity for companies focused on ambulatory products and specialist products sold in the
ambulatory market by specialist doctors. As such,
the company is financially sustainable and is probably one of the best companies in terms of value in
the stock market.
Part of Jaba Recordatis strategy involves expansion to the Portuguese-speaking African countries
(PALOP), primarily Angola, Mozambique and Cape
Verde. Pires plans to create Jaba Recordati affiliates in these countries, starting with Angola. It is
not normal for an affiliate of a multinational to become its own small multinational, Pires states. Like
many other companies in Portugal, Jaba Recordati
has taken advantage of its cultural and linguistic
connections to these nations to expand business.
We supply European health technology to African
countries, training health technicians and doctors,
and sponsoring congresses and scientific activities, continues Pires. Most companies solely export without creating local links, whereas I believe
we should create an internationalization business to
create local value. After establishing a local affiliate
with the right partner, we can develop a link with local stakeholders.

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past couple of decades, except German
company Fresenius Kabi. The organization purchased local manufacturer
Labesfal in 2005, and this has turned
out to be a very strategic move on Fresenius Kabis part. Through this acquisition we acquired all the complexity,
size and content of Labesfal, as well as
the knowledge, expertise and resources
that Labesfal had in the field of IV generics, explains Fresenius Kabi Portugal
general manager Hernni Srio. The
company wanted to create a competence
center in Portugal for the development
and production of IV drugs, and in doing so the company increased its position
in the pharmaceutical sector in Portugal
and became one of the biggest providers
of IV drugs for the hospital sector. As
of today, Fresenius Kabi is the biggest
exporter of pharmaceutical products
according to the National Statistical Institute of Portugal, and its facilities are
approved to produce for Europe, Latin
America, Middle East, and Asia-Pacific.
Similarly, Portugals health-related
exports have actually been experiencing
year-on-year increase for a number of
years; in 2012 sales from medicine exports finished at EUR 600 million (USD
780 million), and EUR 700 million (USD
910 million in 2013. Including other related products like medical devices, 2013
totaled EUR 1 billion (USD 1.3 billion).
Latin America and the Portuguese-speaking African countries (PALOP) are often
targeted first because of Portugals historical connections to these places. For
CMO Iberfars president Pedro Ferraz da
Costa, Iberfars fastest area of growth
and biggest opportunities today are in
Angola, where we have a 140-person operation with USD 40 million turnover, a
partnership with two other companies
and a 20 percent growth rate. The government is trying to expand healthcare to
a bigger part of the population and it is
working. The price level and margins are
very high, so it is a healthy business with
expansion possibilities. From Angola we
think we can build up an operation that
would cover southern Africa.

Public Selling Price (PSP) development


The total market decrease in price started in 2011

17,0
15,0
13,0

Total Market
0,6%

13,01

2,6%
2,3%
13,35

13,05

25,0

% Growth

1,1%
5,9%
13,20

11,0

6,5%
13,8%

20,0

19,89
18,18

19,8%
14,57

10,71

9,0

10,01

% Growth

10,0

24,0%
32,0%

13,73
10,43

7,10

7,21

2012

2013*

5,0

7,0

1,5%

5,8%

8,6%

15,0

12,42

Generics

3,2%

0,0

5,0
2007

2008

2009

2010

2011

2012

2007

2013*

*2013 projection based on accumulated May data

can science = profit?


Portugal is frequently hailed for the excellence of its scientific output, given the outstanding quality of the numerous research
institutes that exist in this relatively small
country. The country has grown significantly in terms of research and PhDs, the
younger generations are highly educated,
and Portugal has some of the best ranked

2008

2009

2010

2011

*2013 projection based on accumulated May data

universities in the world for healthcare


and engineering, comments Pedro Gonalves, Secretary of State for Innovation,
Investment and Competitiveness under
the Ministry of Economy of Portugal.
But we need to be able to transform that
knowledge more actively and effectively
into creating an economy that is technologically more advanced, and into products and services that incorporate more

Pioneering science delivers vital medicines

Transforming the language


of life into vital medicines
 "!" 
"  
 #" 
   !
  $#
!!
    !
!"""

%   !

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Orphan drugs and austerity


In Portugals continuing struggle to
adapt its reimbursement system, orphan drugs are at the center of the
debate. Health authorities in Portugal
have not updated Portugals reimbursement system in decades, and
thus are not adapted to the modern
realities of innovative medications like
orphan drugs. This presents some
challenges for companies specialized
in this niche. Fermin Rivas Lopez, the
Spanish country manager of Celgene
Portugal, remains optimistic. Its
less difficult to defend the use of Celgenes products since we bring value
and strong data regarding survival and
clinical value of products, says Rivas.
Since Celgenes products are orphan
drugs, the number of patients and budget for hospitals is lower. I think that
we are in a very good position to de-

From left: Ramn Palou de Comasema,


Country Director, Amgen Portugal; Fermin
Rivas Lopez, Country Manager, Celgene
Portugal

fend the use of our drugs given the low


level of budget impact, and high level
of investment in Portuguese clinical trials. The Portuguese affiliate conducted seven clinical trials in 2012 and
increased this number to 11 in 2013.
Amgens Portuguese affiliate is in
a similar situation. Amgen needed

to maintain its current structure in


terms of product sales and work on
new products in our pipeline to be
approved in Portugal, explains fellow
Spanish expatriate and country director of Amgen Portugal Ramn Palou de
Comasema. In reality, it has not been
easy to provide access to innovation in
Portugal in the last year. Nevertheless,
Amgen has been successful in the last
few years in demonstrating to the authorities the benefit of our molecule
products first for patients in terms of
clinical value and savings to the health
system, which holds true for all companies. Specifically, Amgen was able
to reimburse three of its products in
Portugal over the last four years. With
14 clinical trials ongoing in Portugal today, Amgen is also a leader in bringing
clinical research to Portugal.

added value. I am responsible for the instruments that give incentives to create such policies, namely incentives to utilize the
human resources the country is graduating. For example, the
Ministry of Economy recently introduced a fiscal benefit commonly used by the pharmaceutical industry, in which expenses
that companies incur for PhDs are accounted for 120 percent.
That means there is a 20 percent gain from which research centers and companies can benefit.
Portugals R&D environment is outstanding, comments
Joaquim Cunha, executive director of Health Cluster Portugal (HCP). However, in order to succeed, our R&D institutions may need to adjust their strategies slightly to be aligned
with the needs of the market.
HCP is a collaborative platform founded in 2008 that
brings together more than 130 members across the Portuguese
health value chain, including universities, R&D institutions,
hospitals, and major private healthcare groups, along with national and multinational pharmaceutical, medical device and
ICT companies. The main driver for its foundation was the
belief in the scientific and technological progress witnessed
in Portugal over the last twenty years. Cunha believes that
by defining the countrys strengths and focusing its efforts on
those strengths, combined with proactive international networking, Portugal can have a dominant role in the life sciences industry globally. Three key words embody HCPs
goals: innovation, collaboration and internationalization,
continues Cunha. The ultimate design is to turn knowledge

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20

portugal report
into value, within the Portuguese health
value chain, while focusing all of our
efforts on the global market. Specifically, oncology and neuroscience could
be the pivotal areas of health science in
which Portugal could excel.

Top 20 Pharma Companies by Sales,


September 2013
1

MSD

Novartis

Pfizer

Bial

Biotech: small But groWing

AstraZeneca

Servier

Daniela Coutu and David Malta,


founders of Cell2B, point out that economically, the cost of doing business
in Portugal is much lower than other
emerging biotech countries, even Ireland. Portugal could be a hub for biotech with high standards of quality and
lower investments to develop products.
Translating basic science into commercial products therefore might be slightly
easier here.
According to Nuno Arantes-Oliveira,
president of Portugals biotech association P-BIO, the weakness of the biotech

7
8
9
10
11
12
13
14
15
16
17
18
19
20

Bayer
Sanofi
Boehringer Ingelheim
GSK
Generis
Ratiopharm
Lilly
Menarini
Medinfar
Merck
Janssen Cilag
Vitoria
Jaba Recordati
Abbott

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Source: IMS Health

From left: Joaquim Cunha, Executive Director,


Health Cluster Portugal; Pedro Gonalves,
Secretary of State for Innovation, Investment
and Competitiveness

sector, especially with regard to the 30


or so biotech companies in Portugal focused on health, has been the companies
lack of capacity to grow beyond the early
stages of development. A few years ago,
there were some barriers to entrepreneurship for startup companies but this
is now changing and it is relatively easy
to start a technology-based company in
Portugal, says Arantes, who notes that
Portugal needs to create the best con-

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From left: Nuno Arantes-Oliveira, President, P-Bio; David Malta and


Daniela Couto, Co-Founders, Cell2B

ditions for the best startup biotech companies to grow as if


they were located anywhere else in the world. Today there are
facilities, incubators, seed funding and venture competitions,
which allow for creation; now the issue is growth. There are no
large private venture capital funds that invest heavily in Portuguese biotech. Historically there has been some state venture
capital that dabbles in several industries and private generalist
venture capital from banks. The recently created Portugal Ventures seems to be an example of the state rationally investing in
specific fields including biotech.
My vision is one of consolidation, focused on the creation of critical mass, which is not exclusive to biotech;
rather they should be part of a movement to specialize the

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country in problem-driven objectives,


concludes Arantes. In biotech, because
some of our companies are at an early
stage, they are flexible enough to go
along with the trend. If it becomes logical that Portugal can be the best in the
world in, say, one specific rare disease,
perhaps there are several biotech companies that are developing technologies Jos A. Aranda
da Silva, General
that could shift into that focus.

Manager, Formifarma

preparing the neW portugal


Portugal may have struggled through some truly difficult
times in recent years, but hitting rock bottom has certainly provided the wake-up call necessary for the country to
bounce back. I believe the market will return to normal levels in the next few years, but the industry must also change
by having the capacity to add value of products in the market
and health system, says Jos Aranda da Silva, general manager of local consultancy Formifarma. We must also invest
more into convincing authorities about the value of drugs,
and shy away from the idea that health and medicine are
economic burdens.

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22

THE HEALTH ECOSYSTEM OF PORTUGAL


PHARMACEUTiCALS

MEdiCAL dEviCES

HEALTHCARE

Turnover: EUR 1.18 billion


(USD 1.53 billion)

Turnover: EUR 319 million


(USD 415 million)

Turnover: EUR 11.22 billion


(USD 14.59 billion)

Employment: 6,196

Employment: 4,573

Employment: 247,630

Number of companies: 133

Number of companies: 985

Number of companies: 82,303

Gross Value added:


EUR 346 million (USD 450 million)

Gross Value added:


EUR 125 million (USD 163 million)

Gross Value added:


EUR 5.03 million (USD 6.54 million)

Exports 2011: EUR 708 million


(USD 920 million)

Exports 2011: EUR 209 million


(USD 272 million)

Increasing rate
in the last 5 years: + 24.3%

Exports 2012: EUR 728 million


(USD 946 million)

Exports 2012: EUR 259 million


(USD 337 million)

Source: INE 2013, SCIE, figures for 2011 (courtesy of AICEP)

PORTUGAL APRIL 2014

23
Biopremier is an international biotech company established in 2003 focused on the
development of DNA tests for food. After a few years of development, the company
started to commercialize its products. At that time, there was still no possible control
in terms of quality and fraud in the content of food through DNA testing, says Pedro
Fernandes Antunes, chairman of the board at Biopremier, which is one of the few
companies in Europe with triple accreditation. In 2012, we started the internationalization of the food sector. AgriFood, the food section of Biopremier, became an international service company in terms of diagnostics for food quality and security. As we
had also reached the end of the development phase in human clinical kits, we were
therefore able to grow abroad rapidly, through our increase in exports and our finalizing of the development of PCR kits.
In addition to its work in the food sector, Biopremier also recently developed two
human kits, one of which responds to a currently unmet need for gastrointestinal diseases, the other for respiratory infections. These kits drastically reduce time to diagnosis from several weeks to a few hours. We are looking at countries that have high
tuberculosis rates like the PALOPs, some European countries, Mexico and southern
US, says Fernandes Antunes. We are fully ready to go international, as we also have
accreditation from Instituto Portugus de Acreditao (IPAC), which is recognized in
52 countries.
As Biopremier continues to broaden its global scope, the company also aims to
develop new techniques and technologies. A company like Biopremier in Portugal
needs to think about the market for which it works, concludes Fernandes Antunes.
We must ask ourselves if our work leads to products that are better than anyone elses.

In the right
place when life is at risk

perating in the medical devices industry since 1986,


Fapomed is dedicated to the production of microbial
barriers on non-woven fabric, being expert in gowns,
drapes and customized sets for surgical procedures
(CPTs).
Has been involved in the fields of Research &
Development, Quality and Production Management in
close complicity with customers and strategic suppliers
in various countries of Europe and Africa as well as in
the USA.
Due to the trust that has been able to achieve over 28
years of experience, Fapomed is proud to say that it is
in the right place when life is at risk.

Av. Dr. Ribeiro de Magalhes, 791, 4610-108 Felgueiras - Portugal


T +351 255 310 680 | F +351 255 310 689 | M +351 964 067 777
E welcome@fapomed.pt | W www.fapomed.pt

PORTUGAL APRIL 2014

24

Interview with: Pedro Gonalves, Secretary of State for Innovation, Investment


and Competitiveness - Ministry of Economy of Portugal

INTERVIEW WITH:

Pedro Gonalves, Secretary of State


for Innovation, Investment and
Competitiveness - Ministry of
Economy of Portugal
PharmaBoardroom: How is the Ministry of
Economy promoting growth throughout the
country as a whole?
PEDRO GONALVES: Our aim as the Ministry
is to promote growth by correcting the
structural imbalance that Portugal has
experienced in the last decade. Only three
countries grew less than Portugal over the
last ten years worldwide leading to very
poor economic performance. We need to
dramatically change the structure of our
economy to become more competitive.
That change is already being achieved. As
an example, in the 40 years preceding
2010, Portugal always had a negative current account. In 2010, it represented more
than 10 percent of GDP. Every year since
then, we had to finance ten percentage
points of GDP in debt. 2013 was closed
between 2.5 and three percent of surplus
on the countrys current accounts. This was
achieved within the Euro, and it is one of
the biggest current account corrections
without currency depreciation.
That recovery was accomplished out of
debt reduction and a huge increase in
exports. In 2010, Portugals exports represented less than 29 percent of GDP; in
2013, exports represented 42 percent.
Every year since 2006 has been a record
for exports, and the pharmaceutical industry has been a substantial contributor. Portugal has certainly accumulated consider-

able debt in many areas related to the


pharmaceutical industry, but simultaneously almost 1.948 billion of debt was
paid between 2011 and 2013. The government is not just trying to reduce debt but
also to correct imbalances that place the
country in order. There is a very strong and
affluent commitment by the Health Ministry, to reduce the debt substantially, and
the normal flow of payments to suppliers
has been reestablished.

PB: The American culture of innovation is


lenient for making mistakes, whereas Europeans tend to be less forgiving. How can you
apply a culture of moderation in Portugal?
PEDRO GONALVES: This requires a change in
mentality, which takes time. Europeans,
especially southern Europeans, have historically penalized errors frequently, and
we should avoid this. Europeans punish
people for mistakes, but we tend to not see
the bigger picture of an effort to innovate.
The idea of giving people second and third
chances is a very American or Anglo-Saxon
mentality. As a consequence, the Ministry
of Economy is implementing an entrepreneurship workshop for young people in
October 2014.
As former IBM chairman Louis Gerstner once said, people do what you inspect,
not what you expect. If you create the right
incentives for behavior, it might provide

Pedro Gonalves, SECRETARY OF STATE FOR INNOVATION, INVESTMENT AND COMPETITIVENESS - MINISTRY OF ECONOMY O
PORTUGAL APRIL 2014

25

everything but it is a very good step in the


right direction. For example, we have revised
our bankruptcy law, which is now more similar to Chapter 11 of the United States Bankruptcy Code. This new law provides protection from creditors, incentivizes new
companies to open, and reduces the cost and
timing for closing a company. We are focused
on creating the conditions for individuals to
be creative and implement companies, and
in this regard we are behind countries like
the US. That being said, today I can create a
company in Portugal, pay corporate taxes
and license out the majority of activities of
that company in less than an hour with an
internet connection. In that sense, Portugal
is becoming very competitive; we have substantially reduced bureaucratic entrance
costs and business closure costs. This mentality of entrepreneurship has to start as
early as high school, and allows us to create
the economic incentives to have more of an
entrepreneurial and venture culture in Portugal.

PB: What do you hope to have achieved by


2020, chiefly with the pharmaceutical sector?
PEDRO GONALVES: I would like to see a country
that is financially balanced, and where
exports represent at least 50 percent of our
GDP. Foreign investors, particularly in the
pharmaceutical industry, should be able to
invest and extract value out of our intrinsic
resources, and Portugal can become a strategic bridge between Europe and other geographic areas as it has in the past. By 2020,
I would love to see more pharmaceutical companies coming to Portugal to invest in R&D
and become suppliers of our national health
system. Companies that come here should be
able to use Portugal as a base to export to
Africa, PALOPS, Maghreb, Brazil and Latin
America, and other countries where we are

By 2020, I would also like to see


Portuguese pharmaceutical
companies becoming more
internationalized, and with more
presence in markets abroad. Bials
recent FDA approval of the first
drug ever developed entirely in
Portugal is a good indication that
we are heading in the right
direction.
growing our exports substantially.
By 2020, I would also like to see Portuguese pharmaceutical companies becoming
more internationalized, and with more presence in markets abroad. Bials recent FDA
approval of the first drug ever developed
entirely in Portugal is a good indication that
we are heading in the right direction. We
want to see more innovative, patent-based
Portuguese products going abroad and competing in the most advanced markets like the
US, Asia, Latin America, and the Middle
East. Lastly, I would like to see more examples of research-based companies and institutions like Gulbenkian and Champalimaud,
which are at the forefront in their respective
fields, creating awareness and benchmarks
in terms of health R&D worldwide.

OF PORTUGAL
PORTUGAL APRIL 2014

Interview with: Manuel Teixeira, Secetary of State for Health Ministry of Health of Portugal

26

INTERVIEW WITH:

Manuel Teixeira, Secetary of State


for Health - Ministry of Health of
Portugal
PharmaBoardroom: What are your current
initiatives and priorities that you would
like to highlight as being emblematic of
your Ministrys commitment to improve
the health of the nation?
MANUEL TEIXEIRA: Portugal has an established National Health System that
answers to citizens health needs, achieving universal access and delivering
remarkably good health indicators. Portugal has gained more life years since
1960 than any other EU member-state,
and has historically reduced infant, prenatal and maternal mortality. Likewise,
we achieved excellent results in differentiated areas. For example, our National
Vaccination Program surpassed coverage
of 95 percent of the entire population and
Portugal has the highest prevalence of
patients living with a functioning kidney
transplant.
In the last two years we have been
pressured to regain fiscal sustainability
following the crisis. We have implemented an amazing cost reduction in the
healthcare system, mainly in input costs
(medicines and labor) without reducing
quality and access to care. Our efficiency
increased by producing more medical
appointments, surgeries and volume at a
lower cost. By doing this we also contribute to national recovery, namely avoiding
adding health burdens to the present-day
economic and social impact of the current
international crisis. Meanwhile, we are

stimulating structural changes for


healthy living policies, integrating transparency between levels of care and creating an environment for competiveness
between providers.
Fortunately, the health system, our
institutions and our qualified health professionals are giving an extraordinary
response to these additional challenges
and maintaining resilience and confidence in healthcare in Portugal.

PB: As a result of austerity, demographic


developments and rising life expectancy,
governments are in the search for meaningful savings in healthcare. What are the
strategic and necessary steps the Ministry
will take to make the Portuguese healthcare system fit for the future and for a new
economic and demographic context while
still incentivizing innovation investments?
MANUEL TEIXEIRA: As a developed and
established health system, we do not face
any particular challenges that differ dramatically from other health systems. It is
true that in spite of healthcare reforms
in recent decades across Europe, costs
pressure continues to rise in each country
in terms of demographics and technology.
For example, our acute care costs
increased 58 percent between 2000 and
2011. Other countries did much worst in
hospital care: the UK increased 86 percent, Spain 100 percent and the Nether-

Manuel Teixeira, SECETARY OF STATE FOR HEALTH - MINISTRY OF HEALTH OF PORTUGAL


PORTUGAL APRIL 2014

27

lands 118 percent. Meanwhile, all countries


are facing anemic economic growth.
We believe that the future of healthcare
system depends on its ability to make care
delivery needs more flexible and innovative.
In the next few years, healthcare should
evolve to integrated care and management
of chronic disease in the community, rationalizing and specializing acute care and
improving the experience of the consumer
in the system.
At this moment we still face additional
challenges due to the economic crisis. We are
committed to regaining our financial independence and accomplish our commitments
within international partners under assistance programs with IMF/ECB/EC. We had
to put in place ambitious measures aimed at
curving our public expenditures into affordable targets. We have made great adjustments focused on efficiency and rationalization of public expenditure. Our primary
focus was on safeguarding access to healthcare and protecting patients. The Ministry
has promoted vast reforms demanding special efforts from health system partners. We
strongly believe that when several players
and providers are interested in partnerships
with the health system, it applies during
good and bad times. Currently we are facing
exceptional challenges and difficulties; we
demanded that our partners must take part
of the effort. That is also what happened with
the pharmaceutical industry; in the last two
years, we established an agreement between
government and pharmaceutical representatives to share the need to reduce revenues in
alignment with mandatory decrease of public and private expenditures with medicines.
By sharing these objectives we also managed
to introduce new medicines for unmet clinical needs and reinforced access to medicines.

What is your action plan and long-term


vision for Portugals healthcare system?
MANUEL TEIXEIRA: We believe that in the long
term, we will continue to have a mainly taxfunded system, but achieving a sustainable
health system remains a challenge in near
future. We still need to reinforce our primary care and achieve global coverage with
family doctors, boosting prevention as an
effective and quality-rated health intervention. Additionally we need to reshape our
hospital network to be driven by excellence
centers. We must also persist in developing
our continued care, allowing better recovery
and integration in society for those who
need healthcare without need for acute care.
We believe that the way we are providing
care will be much more patient/consumer
oriented and more flexibility will be permitted in the provision of care. The need for
flexibility and opportunity for innovation
makes us believe that we must strengthen
our competiveness between providers,
enabling an Internal Public Market to create an institutional purchaser-provider
split, transparency of outcomes indicators
and patient informed choices.

PB: What are the most important lessons to


be learned about the industrys relationship
with the Portuguese health authorities?
MANUEL TEIXEIRA: The Portuguese health system, like the systems of several countries,
is facing huge dilemmas. All stakeholders
most contribute to the answers to those
dilemmas. The pharmaceutical industry is
one of those stakeholders that must be
responsible to contribute as a partner for
better health and financial sustainability.

PORTUGAL APRIL 2014

28

Interview with: Dr. Heitor Costa, Executive Director - Apifarma

INTERVIEW WITH:

Dr. Heitor Costa, Executive Director


- Apifarma
PharmaBoardroom: Could you provide an overview of the most important issues on your
agenda today?
DR. HEITOR COSTA: The Ministry of Health has
elected the pharmaceutical industry as the
main contributor to the adjustment of its
current financial dilemma. As an example,
between 2011 and 2012 the industry contributed 600 million, which represents
more than half of the adjustment made by
the entire Ministry. Restoration measures
with the pharmaceutical industry tend to
be quite easy; decreasing prices, imposing
the lowest prices in Europe based on reference countries, creating restrictive access
measures, and refusing to compensate new
medicines are all easier than merging hospitals or changing policy at the level of the
Ministry. Of course, the Portuguese pharmaceutical industry is the main stakeholder
in the sustainability of the system, whose
stability directly affects the industry. Therefore, companies operating in Portugal have
been cooperating well with the government. There are of course limits, because
the sustainability of the system cannot
endanger the sustainability of local or multinational companies.
Apifarma has 120 members, and is
somewhat unique compared to similar associations throughout Europe in that it covers
not only pharmaceutical companies, but
also generic companies, OTC companies,
medical devices in the field of in vitro diagnostics (IVD), and veterinary medicines.
The troika (Central European Bank, the
IMF, and the European Commission) have

Dr. Heitor Costa, EXECUTIVE DIRECTOR - APIFARMA


PORTUGAL APRIL 2014

imposed a MoU on Portugal to cut total


pharmaceutical expenditure (both inpatient and outpatient) to one percent of GDP,
which is the average for other countries
only for outpatient markets. This would
downgrade Portugals per capita expenditure to one of the lowest in Europe.

PB: Access to innovative medicines in Portugal is one of the lowest in Europe. What can
the industry do to ameliorate this situation?
DR. HEITOR COSTA: Portugal must follow the
rest of Europe. The Portuguese government
should immediately implement innovative
risk-sharing agreements with companies.
The industry can share the responsibility
with the state in terms of providing new
medicines needed for patients while
respecting the sustainability of Portugals
healthcare system. This country needs
access to innovative medicines like anywhere else, but there have been lack of new
reimbursements in Portugal for two and a
half years apart from those ones recently
reimbursed under the framework of the
Agreement Government-APIFARMA of
2013. I know some risk sharing agreements
have been designed for the introduction
and approval of some medicines, but some
of them are still not in the market. Access
is only provided through special authorization, which is not ideal.
Hospital debt is another challenge for
Apifarma and the industry, which has
financed the system for two years. This cannot continue anymore. Portugal has been
in Europe for a long time, but it seems like

29

the country is leaving Europe because of this


lack of access to new medicines to fulfill
unmet medical needs. Sustainability is one of
the main preoccupations of all companies here
and elsewhere in Europe. The industry should
share risks in that sustainability while still
maintaining access to innovation; the state
currently designs the market for each company, which creates uneven competitiveness
and is generally incomprehensible.

PB: In 2009, Portugal had 147 clinical trials


running, lower than similar-sized countries
like Austria, Czech Republic or Belgium. What
is the current status and future potential for
clinical trials in Portugal?
DR. HEITOR COSTA: Portugal is not implementing its full potential in this regard. Per capita
investment here in terms of number of
patients involved is below most European
countries. Apifarma has been working hard
to incentivize pharmaceutical companies with
affiliates in Portugal to invest in clinical
research. The problem is that the involvement
of patients in clinical trials is very competitive, and Portugal is usually not a priority for
companies looking to fill enrollment. Furthermore, Portugal has had issues with assessments for trials, as well as with data protection committees and hospitals as they are the
last in the value chain to approve contracts.
These issues can be overcome as hospitals are
creating special units to develop clinical trials
within.
PB: How has the manufacturing industry
evolved since the start of the recession?
DR. HEITOR COSTA: The manufacturing industry
has expanded greatly, and is the main contributor of health sector exports. There is
potential to grow more, and the export of
medicines in Portugal has rapidly increased
in recent years. By the end of 2013, Portugal

will have exported over 700 million in medicines, and total sales in 2012 were 600 million, more than port wine. Including other
contributions like medical devices, Portugal
exports more than 1 billion per year in the
health sector. The industry is also looking to
increasingly diversifying markets. PharmaPortugal, an Apifarma project for product
export that combines all pharma companies
with factories in the country, has been targeting markets beyond Europe to regions like the
Middle East and Latin America.

Heitor Costa
with the
Pharmaboardroom
team, Emilie
Laumond and
Cameron Rochette.

PB: What does the international pharmaceutical community need to know about Portugal?
DR. HEITOR COSTA: Continue to invest in Portugal, because being here is important for Portuguese patients and indeed the entire country. Without pharmaceutical companies
medicines they will not be properly treated.
Companies here are contributing to our economy not just through patients but as employers. Try to invest more in our patients and do
so for economic reasons. It is achievable that
through Portugal, companies eventually will
be able to have facilitated access to other markets like African countries.

PORTUGAL APRIL 2014

30

Interview with: Joaquim Cunha, Executive Director - Health Cluster Portugal

INTERVIEW WITH:

Joaquim Cunha, Executive Director


- Health Cluster Portugal
PharmaBoardroom: Could you introduce our
readers to HCPs main activities?
JOAQUIM CUNHA: HCP is a collaborative platform founded in 2008 that brings together
more than 130 members across the Portuguese health value chain, including universities, R&D institutions, hospitals, and
major private healthcare groups, along
with national and multinational pharmaceutical, device and ICT companies. HCPs
foundation was based on the belief in the
scientific and technological progress witnessed in Portugal over the last twenty
years. The countrys scientific potential has
also been recognized by the international
scientific community. Portugals healthcare system, although developed slightly
later than the healthcare systems of most
European countries, is now globally very
well-ranked.
Three key words embody HCPs goals:
innovation, collaboration, and internationalization. The ultimate design is to
turn knowledge into value within the Portuguese health value chain, while focusing
all of our efforts on the global market.
Interestingly, Portugals R&D system is
somewhat internationalized as seen
through research collaborations with the
US and northern Europe established in
recent years. However, it still lacks internal cooperation. In doing so, Portugal can
learn how to be competitive and collaborative abroad. HCP can help create that network, which will develop our critical mass.
By promoting cooperative projects, making connections between companies and

R&D institutions, and removing existing


bureaucratic barriers that still exist, we
can achieve our focus.
Portugal is about to enter a new era. We
are preparing a new period of development
through a framework program called Portugal 2020. As our country emerges from
recession, the government is launching an
agenda for reindustrialization. I strongly
believe that an effective and well-defined
strategy to increase industrial work must
involve smart specialization. This
requires evaluation of areas where Portugal has exceptional scientific and clinical
competencies, and the alignment of these
competencies with global needs. These will
most likely include specific niches within
the fields of oncology and neuroscience.
We are also working on some other initiatives, such as having more presence in
European platforms and networks, particularly related to translational research.

PB: What factors have lead to the perception of Portugals low ranking for innovation?
JOAQUIM CUNHA: In the context of science
and innovation, and specially in what concerns healthcare, southern countries tend
to fail in maintaining a good reputation
and this is mostly our own fault. We do not
sell our image properly. Excluding scientists and medical professionals, northern
Europeans tend to perceive southern Europeans as less motivated and efficient.
While this is not true, we have not been
efficient in building up another image.

Joaquim Cunha, EXECUTIVE DIRECTOR - HEALTH CLUSTER PORTUGAL


PORTUGAL APRIL 2014

31

Therefore, we must create a collective strategy to turn this around. HCPs ambition is
to provide a positive contribution to build
this strategy. We have no doubts about our
healthcare systems competencies, the quality of our tourism providers, or the interesting geostrategic position of Portugal in the
world.

PB: How does HCP facilitate a business-oriented mindset in innovation?


JOAQUIM CUNHA: HCP is committed in raising
awareness on this (and other relevant issues);
in informing and training the key stakeholders of the health value chain (universities,
research institutions, hospitals, industry,
policy makers) on technology transfer and
intellectual property protection and exploitation; in promoting the networking between
academia and industry in order to contribute
to change the paradigm of knowledge exploitation and valuing. HCP is also very committed in facilitating access to high-quality services in the area of intellectual property.
Since 2012, we support the participation
of our members on the European funding
programs. Our objective is to bring together
and promote network between national entities, top European universities and leading
companies because we have to work with the
best. We may choose the more expensive or
tougher option, but it is the only way to be
globally competitive. This is a global game,
and you have to work and cooperate with the
best.
PB: What is Portugals number one competitive advantage that the rest of the world
needs to know about?
JOAQUIM CUNHA: Undoubtedly, this is human
resources. Portugals human resources are
very well qualified and competitive, while
being affordable.

Portugals R&D environment is outstanding. However, in order to succeed, our R&D


institutions may need to adjust their strategies slightly to be aligned with the needs of
the market. I would also like to refer our governments initiatives in creating the best conditions to attract FDI. However, having a
strategy to attract FDI and foreign companies only based in low taxes may not be
enough. And so we are working on the environment; this means including not just R&D
and industry but also healthcare and clinicians in the equation, since the relation
between clinicians and the R&D system is
becoming more connected. In the past, there
were no habits of cooperation between science and healthcare. Things are changing
now as more resources are being shifted to
applied research. We have to come out of the
comfort zone and compete globally, finding
our niche and place.
Where do you expect HCP to be by Horizon
2020?
JOAQUIM CUNHA: By 2020, I would be happy to
see a knowledge-based economy in Portugal.
In health, this strength in knowledge will be
our vision for the future. We have to select
niches and define our assets and priorities
as the world succeeding economies have
done. Our cooperation with PALOPS and
with the emerging economies of South America, North Africa and Middle East based on
cultural links will provide us with a competitive advantage. Additionally we still need to
reinforce our presence in the most demanding markets such as Europe and United
States.

PORTUGAL APRIL 2014

32

Interview with: Abel Vizeu Fernandes, Country Director - Kedrion Portugal

INTERVIEW WITH:

Abel Vizeu Fernandes, Country Director Kedrion Portugal


PharmaBoardroom: You were offered the
opportunity to establish this affiliate in
2010. What was your initial mandate?
ABEL VIZEU FERNANDES: At that time, no
stakeholder knew of the Kedrion name in
Portugal. After establishing offices and
hiring new people, my first goal was to
establish a communication plan to sell the
image of the company and the quality of
its plasma-derived products to the relevant stakeholders. I visited all hospital
stakeholders, which included not only
hospital pharmacies but also physicians
and other individuals with purchasing
power. This business is very linked with
tenders, and it is crucial to create relationships with purchasing partners and hospital administrators. I did this with hospitals across the entire country. Three
years later, every Portuguese hospital
knows Kedrion and has asked for proposals for our products. Additionally, I created relationships with INFARMED, various patient associations, and government
stakeholders.
PB: How has the plasma market in Portugal
been affected by the crisis and hospital
debts?
ABEL VIZEU FERNANDES: Portugals plasma
market is unique. Until 2010, Octapharma
was the big player in this market with
about 95 percent market share in the
industrys most important products like
immunoglobulin or albumin, due to the
organizations strong history in Portugal.
Our job, in addition to other players, is to
compete with this monopoly. Kedrions

Abel Vizeu Fernandes,COUNTRY DIRECTOR PORTUGAL APRIL 2014

KEDRION PORTUGAL

strategy has been to explain to hospital


pharmacies and physicians the competitiveness of the companys products in the
European context and why they should
open a tender for these particular products. In 2013, the Portuguese health
authorities opened national tenders for
plasma-derived products for the first time
since 2008. This new tender opened an
opportunity for all plasma companies to
position proposals. Now these companies
can participate and the business is spread
over a level playing field, drastically
changing who the main players in Portugal are.

PB: How were you able to demonstrate


added value to the health authorities?
ABEL VIZEU FERNANDES: We are working
with government (INFARMED) to look for
plasma-derived products situation in Portugal. Plasma protein therapies have a different coststructure than traditional
pharmaceutical products. This is due to
the cost of the plasma and the complex
manufacturing process.
The cost of plasma is high and actual
commercial margins are low. There has
been some improvement due to the governments recent law enforcing public hospitals to pay for supplies within 90 days.
Given the general price decrease of products over the last three years, this can be
an issue for companies like Kedrion.
Because of plasmas shortages and the difficulties associated with donors and manufacturing, production costs are high.

33

PB: The plasma market is some decline due to


more modern products being developed. How
do you adapt?
ABEL VIZEU FERNANDES: There are less new and
innovative products in this market niche.
However, there are improvements that are
made to individual products. For example, an
immunoglobulin product used intravenously
may be in higher concentration, thus reducing
a patients time in hospital significantly.
Kedrion focuses intensely on the quality and
safety of its products, particularly in manufacturing. Continuous innovation in the manufacturing process and the long and complex
production bring their own unique pressures
on the economics of production. This is important when convincing local authorities about
the safety and efficacy of our products.

PB: How is Kedrions product portfolio represented in this affiliate?


ABEL VIZEU FERNANDES: Our most important
products are albumin and IV immunoglobulin. These products represent 90 percent of
business in Portugal. Kedrion will start selling
two products this year for liver transplants
and for hemophilia A and B. Historically,
Octapharma has been in charge of the hemophilia business; in 2012 Kedrion introduced
its own products to Portuguese physicians,
patient associations, and hospital pharmacists, highlighting our market leadership for
hemophilia in several other countries like
Italy, Russia or Hungary. Rare diseases are a
very niche market, and you have to convince
the authorities, pharmacies and patient associations of this.

PB: Could Kedrions products be considered for


the retail market in Portugal?
ABEL VIZEU FERNANDES: In Portugal, this is not
the case. Some products can be bought as
retail in a country like Germany, but in Portugal all these plasma products are hospitalbased. This is because these products need to
be very well-controlled. When a product like
immunoglobulin is sent to a patient every single detail related to the patient is provided
because of the stringent control environment
associated with these products.

PB: How could Kedrion Portugal serve as a platform to enter the PALOPS markets?
ABEL VIZEU FERNANDES: This subsidiary does not
look at the PALOPS markets because of the
way the organization is commercially divided.
Africa and Latin America are run from Italy.
Europe, Middle East and Asia are run from
Austria, and North America is controlled in
the US. Occasionally, we help our colleagues
in Italy for countries like Angola because of
the cultural connection.

PB: How has the shift in authority to hospital


administrators in Portugal changed the way
you approach hospitals?
ABEL VIZEU FERNANDES: Today, committees of
hospital pharmacies have a major role in final
decisions. Now, we have to work with members of committees to discuss the efficacy and
pharmacoeconomic advantage of a product.
Physicians have less decision-making power
now because of this increased emphasis on
pharmacoeconomics.

PB: What are your expectations for the next


five years?
ABEL VIZEU FERNANDES: In the next five years
Kedrion will become a very important player.
Our current market share here is at five percent after two years of activity. With this new
tender, the affiliate can achieve at least 20 to
25 percent of market share in the next five
years. Essentially, our goal is to become one
of the most important companies in this
area.

PORTUGAL APRIL 2014

34

Interview with: Alberto Inez, General Manager - Sanofi Portugal

INTERVIEW WITH:

Alberto Inez, General Manager Sanofi Portugal


PharmaBoardroom: Portugals health budget will be slashed by 9.4 percent in 2014,
in addition to a 250 million cut in
healthcare expenses. What are the implications of this for the industry?
ALBERTO INEZ: We need to determine how
we can improve in terms of being sustainable by providing the best healthcare
practices. Because Portugal has already
been suffering from an uncertain economic situation over the past two years,
most companies have adopted several
measures to manage in this environment. The industry is working to find
common understandings and best pract ice s w it h t he He a lt h M i n i s t r y,
INFARMED, public hospitals, and even
consumers in order to stabilize costs.
Sanofi is working as a global company in
order to address the challenges of the
authorities current cap.
If we can bridge the problems of the
last couple years with current positive
growth forecasts, this will lead to a new
era, and innovative drugs for patients
will once again be available in Portugal.
We believe that the authorities are making their best efforts to sustain and balance health expenses, which includes
public hospitals and healthcare professionals.
PB: How can stakeholders engage one
another in order to ensure that the access
to innovation happens?
ALBERTO INEZ: Innovation is part of the

Alberto Inez, GENERAL MANAGER - SANOFI PORTUGAL


PORTUGAL APRIL 2014

portfolio, and involves the launching of


new medicines. Every company in Portugal needs to deliver innovation because
new drugs that are available in other
countries must be available here too. If
pharmaceutical companies negotiate
their portfolios successfully with the
authorities, they will be able to open the
tap of innovation for new launches,
instead of creating new expenses. Sanofis internal strategy is to be present in
every segment of the pharmaceutical
sector. For example, if we provide the
country more generics, downsizing the
costs for this segment of products, it will
allow the authorities to deliver innovative medicines for rare disorders, oncology, or neurology.

PB: How is the portfolio of Sanofi represented in Portugal?


ALBERTO INEZ: We are waiting for reimbursement approval for four NDAs
between 2013 and 2014. The growth
drivers for 2014 include a strong focus
on diabetes. We want to be perceived as
a diabetes-focused company because the
majority of our R&D investments are
focused in that area. We are also very
focused on oncology launches, an area to
which we dedicate a large portion of our
research. Sanofi can achieve a good position in the oncology area in Portugal,
although we are still waiting for some
reimbursement processes to be concluded. Therefore, we will also invest in

35

generics to balance out the system, in addition to being a sustainable partner in our
OTC division, which is not reliant on reimbursement.

PB: What has been the outcome of Sanofi


Portugals investigation and investment in
clinical trials for several molecules a few
years ago?
ALBERTO INEZ: Sanofis research in Portugal
is mainly focused on different clinical
studies. The company also evaluates what
kind of startup research companies are in
the market and what they are doing in
order to help them with their needs and
promote stronger partnerships. We do this
through business development, as there
are a huge number of clinical studies that
we can bring to Portugal in many therapeutic areas. Sanofi used to invest between
1 million and 2 million in clinical trials
in Portugal annually. When the economic
situation turned stagnant, the company
had to re-evaluate this important area.
Sanofi is now trying to return to its previous rate of R&D investment, and at the
moment is engaged in two clinical studies
for diabetes, one in rare disorders, and
another in neurology. These trials demonstrate to the authorities our commitment
to local research and especially to Portuguese patients.
Sanofi is also part of the Health Cluster
Portugal (HCP), an aggregation of more
than 50 companies aiming to improve
research and health politics in Portugal.
HCP supports and continually finds applications for research attracts clinical trials
to Portugal. The group also actively seeks
companies to support such investments
that may not necessarily be healthcarerelated.

PB: Sanofi is strongly committed to social


initiatives; how is this implemented in Portugal?
ALBERTO INEZ: Sanofi Portugal promotes a
prize of sustainability to identify, recognize
and share best practices in health. Given the
current challenges of the healthcare systems sustainability, healthcare institutions
and organizations are optimizing the management of their resources. In this context,
Jornal de Negcios and Sanofi established
the Sustainable Health Award to distinguish institutions (Organizations Award)
and their leaders (Personality Award) that
stand out because of their promotion and
implementation of sustainability principles
with tangible impact on society. Accenture
is responsible for the development of the
assessment methodology.
The prize has two different categories: 1)
institutional awards with the sub-categories primary care, hospital care & continuity
care; 2) Personality Award which nominations will be proposed by the members of
the Jury of the prize.
PB: What would you like to have achieved in
the next three to five years?
ALBERTO INEZ: We are implementing Iberian
synergies, thinking globally and acting
locally. In the next five years, we will continue to invest in innovation and manage
our great portfolio with the Portuguese
reality in mind and never forgetting patients
and physicians. We will continue to focus
on patients, independent of weight and
severity of disease. From a medical and pedagogical perspective we will also continue
to expand our social responsibility projects
and strengthen our ties with healthcare
stakeholders. In the next few years I would
like to see Sanofi as an even bigger, better
and more active company in Portugal.

PORTUGAL APRIL 2014

36

Interview with: David Malta and Daniela Couto, Co-Founders - Cell2B

INTERVIEW WITH:

David Malta and Daniela Couto,


Co-Founders - Cell2B
PharmaBoardroom: What do you see as Portugals capacity for the local life sciences
industry to grow?
DM: Portugal is one of the best positioned
countries to grow for life sciences today
because it has one of the best human
resources pools from which to extract.
Portugal has one of the highest per capita
PhD levels in life sciences in Europe, and
the government has been investing
noticeably in life sciences, driving companies to innovate and move forward.
DC: In terms of GDP, Portugal also has
received a large amount of EU and ERC
grants in recent years. The numbers indicate that there is a growing critical mass
in the life science sector within the Portuguese community.
PB: What distinguishes Portugal for biotech?
DM: The cost of doing business in Portugal
is much lower than other emerging biotech countries. Combined with high quality standards, translating basic science
into commercial products could be slightly
easier here. There is also great proximity
between companies, research centers and
even the government to move Portugal
forward in life sciences. INFARMED and
health authorities in general are easy to
access. There has also been a lot of public
money coming into biotech and life sciences in general that can help catalyze by
matching private investments, working
as non-dilutive funding.
DC: Portugal also has an historical con-

David Malta and Daniela Couto, CO-FOUNDERS - CELL2B


PORTUGAL APRIL 2014

nection between Africa, South America


and Asia that as a fairly small country can
be very well explored. Being between
Europe and the US also creates a good
connection. Instead of looking at Portugal
as an entry platform to Europe, you can
actually look at Portugal as an exit to rapidly growing emerging markets.

PB: How do you see the potential of the


public venture capital market to help life
science companies in Portugal grow?
DM: The venture community of Portugal
still struggles to properly evaluate and
fund life sciences projects, mainly in
terms of moving from seed funding to
Series A funding. But this is true across
Europe. In parallel, there is a lot of grant
money available in Portugal for R&D and
life science companies, which can capture
that money more than venture capital
funds. There has still been a significant
level of investment in biotech companies
that was typically matched with government grants. Together they could catalyze
the emergence of a new generation of
companies in Portugal, which are yet to
grow.
PB: Does Cell2B offer a good model for finding a niche for Portugal?
DC: I hope we can become a good role
model in the future! Cell2B is a very earlystage company. We have strong investment through PhDs and research centers
in cell-based therapy with CMOs that
have attracted many clients worldwide for

37

clinical trials. Portugal has the infrastructure to support startups in this area; while
there has not been a major investment in
all life sciences, cell-based therapy certainly
has shown strong interest. 20 percent of
P-BIO companies are related to cell therapy
and regenerative medicine, which is significant.

PB: How was Cell2B established?


DM: Cell2B was borne out of collaboration
between an oncology hospital and the stem
cell lab at the Technical University of Lisbon.
We started by treating patients with acute
graft-versus-host disease (GVHD). Historically, patients have been treated based on
hospital exemptions, and results have consistently been positive. We have a pool of six
treated patients, all of whom survived with
no recurrence of the background disease
itself. That provided a strong incentive to
create Cell2B, since the survival rate of
GVHD is usually between five and 30 percent. In 2011 we incorporated Cell2B with
the intention of continuing to treat patients
through clinical trials. In 2012 Cell2B closed
the first series of investment with various
business angel investors through seed funding. Now we are raising Series A funding for
clinical trials. We have orphan designation
in Europe for GVHD and we have positive
feedback from the EMA to start clinical trials, which we will do in 2014. Additionally,
according to our hypotheses, the underlying
mechanism action also has the potential to
treat other immune and inflammatory diseases. The first Phase I/II and safety studies
will take place in four countries and as we
move on to later stages we will move to more
countries beyond Europe.
PB: What makes Cell2B the partner of choice
among all the cell-based therapy companies

Cell2B is the most developed biotech


company in Portugal, and the only
one ready to start clinical trials with
a clearly defined lead product and
with positive feedback from EMA to
move forward.
in Portugal?
DM: Cell2B is the most developed biotech
company in Portugal, and the only one ready
to start clinical trials with a clearly defined
lead product and with positive feedback from
EMA to move forward. Cell2B is at the forefront of an emerging cluster because of our
development cycle.

PB: What is the market potential of your technology if it becomes commercialized?


DC: The immune area is very large. We are
now running animal studies for other diseases to prove that there is a potential to
treat diseases such as RA, IBD, or Crohns
disease, all of which have large markets.
Looking at GVHD alone, the market is $2.9
billion in just Europe and the US. With current standard of care, mortality rates are
quite high for the most severe cases of acute
GVHD resistant to first line treatment, as I
mentioned. They are not effective for
patients. This makes GVHD a very appealing
market, even as an orphan disease.
PB: What are your ambitions for Cell2B in the
next five years?
DM: We want to have completed the first
development cycle for GVHD treatment, and
being at or close to market approval for this
treatment.

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38

Interview with: Eduardo Pinto Leite Director General, GSK Portugal

INTERVIEW WITH:

Eduardo Pinto Leite, Director


General - GSK Portugal
PharmaBoardroom: You started running this
affiliate in 2010, before Portugals bailout.
What measures did you take to adapt to the
crisis?
EDUARDO PINTO LEITE: The whole country
had to readjust. GSK was no exception,
because as a company we had been dealing
with genericization of a couple of our most
important products annually, and the
retail market had been recurrently declining by ten percent on an MAT basis for a
few years. Today, the market is decreasing
slightly less, but these two factors required
readjustment to become an organization
fit for the current environment and strong
enough to get out of the crisis. We readjusted our P&L, and allocated the minimum but necessary resources to move on.
I do think there will be better days, and
there is a light at the end of the tunnel. The
economy has to pick up; and when it does,
then so will GSK. At that point we will
decide if we are going to invest in more
people.
PB: How difficult is it to maintain a balance
between access to medication and ensuring
debts are paid?
EDUARDO PINTO LEITE: This is a hospital problem, not retail. Retail tends to pay a bit
faster, and while wholesalers have experienced problems in Portugal, overall GSK
is getting paid. My business is mainly
retail, although it will become more
focused on hospital business in the near
future. But the answer is the same. The
industry and GSK have a mission to pro-

Eduardo Pinto Leite, DIRECTOR GENERAL - GSK PORTUGAL


PORTUGAL APRIL 2014

vide medicines to patients. We are maintaining a supply of every medicine to


patients even though they do not pay,
because we cannot leave patients without
medicines. You just have to ensure your
debt is paid.

PB: How is GSK Portugal a good partner


between various payers and stakeholders?
Sometimes there is not enough collaboration.
EDUARDO PINTO LEITE: As vice president of
Apifarma, we maintain a stance of dialogue, which always prevails. The industry
is here because it has been given a license
to operate for society. Although conditions
are rough, the Ministry of Health knows
the industry is here to stay. The industry
does negotiate, but our main concern is
that patients get the drugs they need. This
is demonstrated by the fact that we have
already created an addendum in our second protocol that allows us to move on
through another year without the government taking rougher measures and without us being removed from dialogue. Our
main purpose is to find as many win-win
positions possible. For instance, GSK has
put together a long term initiative with
Janssen called Latitude, which is designed
to find solutions to ensure that innovation
is sustainable. The entry and access to
innovation from Portuguese patients as a
sustainable future in the presence of ever
tighter budgets is the ultimate objective.
PB: What is the strategic importance of GSK

39

Portugal in relation to the organization?


EDUARDO PINTO LEITE: GSK Portugal is now
integrated into a new region with Spain. That
is why we have readjusted from a P&L perspective; this affiliate is now one of the fittest
subsidiaries in Europe. We are a relatively
small organization but sufficient enough to
commercialize products, as they should be
here. Portugal is a country of 10 million people. Our importance will continue to be the
same. The prospects of growth are possibly
even better than in some of our other affiliates. This subsidiary has reached the bottom
and there is now the prospect of growth.
Having growth is a critical success factor, no
matter what the size of the country.

PB: Does GSK participate in clinical trials


here?
EDUARDO PINTO LEITE: No. However, the opportunity for investment in clinical trials certainly exists here on an intellectual basis.
The problem is that the entire clinical development environment set up here has historically been very adverse, and that is why
many companies removed their investment
from here.
PB: Were you ready to take on the crisis based
on your prior experiences?
EDUARDO PINTO LEITE: During my Russia
assignment in 1998 there was a financial collapse, and I have had exposure to a number
of different environments which has helped
me to remain vigilant and have a third-person perspective during these times. In terms
of motivation, Portugal is now on a growing
curve, and this is linked to stability.
PB: What is your strategic vision for the next
five years?
EDUARDO PINTO LEITE: Our main objective is
to grow faster than the market. Growth is

We have a very productive pipeline,


and the challenge for the next five
years is to ensure that we can launch
all those products sooner rather than
later in an environment that has
been very reluctant to approve
innovation.
critical; but you have to grow more than
your peers or the market against which you
compare yourself. From a shareholder perspective, you want to put your money in the
fastest growing company on a sustainable
basis. I want to lead in our operating therapeutic areas, and to be able to launch everything that is coming out of R&D while
ensuring patients can access such products.
We have a very productive pipeline, and the
challenge for the next five years is to ensure
that we can launch all those products sooner
rather than later in an environment that
has been very reluctant to approve innovation. That is one of Portugals key issues. If
you take two or three years to approve a
drug that has already been in Europe for
two or three years, you are denying access
to patients and taking away time for the
valid patent life of the product. This makes
Portugal less attractive for investment
because innovation is not being introduced.
In a nutshell, GSK needs to maintain sustainable growth, lead in the areas in which
it operates and ensure innovation is made
accessible to patients.

PORTUGAL APRIL 2014

40

Interview with: Francisco Velez, Director General - toLife

INTERVIEW WITH:

Francisco Velez, Director General toLife


PharmaBoardroom: What were the challenges
surrounding the creation of toLife?
FRANCISCO VELEZ: The companys entry in
2004 was a bit late since generics entered
Portugal in 2002. Nevertheless, we accelerated some processes in order to register
a couple of products. Our fast market
entrance procedure resulted in the continual launching of new products, primarily
in psychiatry and neurology. Our expertise
in these areas differentiated toLife from
its competitors, since generics for psychiatry and neurology are less well known and
developed. toLife was able to create real
knowledge and awareness among pharmacies and doctors. By 2007, toLife was
already among the top ten generics companies in Portugal due to its fast market
entrance policy. At this point, the company
expanded its portfolio to other therapeutic
areas. Additionally, times were already
tough by 2007, and to maintain a startup
company with a small critical mass was too
difficult and involved high risk. I sold toLife to Esteve, which is a multinational with
startup company values like toLife, and
the organization allowed me to develop
the company as I saw appropriate. The integration was therefore fairly easy.
PB: toLife markets and sells 65 products in
11 therapeutic areas; how are you able to
manage such a broad portfolio for a smaller
company?
FRANCISCO VELEZ: We chose psychiatry and
neurology at the beginning because they

Francisco Velez, DIRECTOR GENERAL - TOLIFE


PORTUGAL APRIL 2014

were strategic, and because awareness of


these markets needed to be created. Once
we had established portfolios in those
two areas, we were comfortable enough
to move into other important areas like
cardiology and gastroenterology among
others.

PB: How has recent government encouragement to use generics in the marketplace as
a means of cost-cutting helped toLife?
FRANCISCO VELEZ: In normal conditions, it
makes sense to have generics. The pharmaceutical industry is extremely profitable. Pharma companies invest five to ten
years and a great deal of money researching products; once they do, they need the
time to receive payback from those investments. Once a products patent expires,
companies should not receive the same
amount of money for that product, and
there is no reason why a patient should pay
exactly the same, especially if it is being
reproduced at a very low cost. The primary
difference is that generic companies are
paying with fewer margins than innovators. Therefore, the structure of a company
like toLife needs to be different because it
does not have the same spending ability
as a multinational with originators.
PB: What is your assessment of patent timelines in Portugal?
FRANCISCO VELEZ: We need clear-cut roles
in terms of patents. Companies need to be
aware when a products patent ends in

41

order to timely introduce a generic to the


market. There is too much litigation in the
Portuguese market. I would say that, for
every five products that hit this market,
there are four litigations. This is not normal.
There are very unclear definitions in terms
of patents that create this litigation. This is
not good for the market or generic companies, it costs a lot, and it does not create nor
stability nor credibility.
Portugal only had process patents for
many years, which was very good for innovative companies. The balance of product patent protection changed when generics were
introduced in Portugal. The time between the
end of a process patent and the beginning of
a product patents start on the market is too
long and generates confusion, which leads to
doubts about the market. As a result, many
multinationals tried to take advantage of
this patent confusion. Until one and a half
years ago, toLife simply had preliminary
injections of registered products in
INFARMED. If any innovative company was
aware of such product registration, that company could stop the approval program
through an administrative court. Such courts
are not the right place to decide on patents.

PB: What explains the success of toLife?


FRANCISCO VELEZ: We have created a deep
benchmark of successful and unsuccessful
companies. Hard work is required to build a
solid portfolio, and excellent people are the
key to success. I hired individuals with high
sales potential and the ability to form good
relationships, but with zero experience in the
pharmaceutical industry. After rigorous
training for eight weeks, these individuals
knew exactly how to interact with our key
partners, doctors and pharmacies. Once we
obtained credibility with doctors and pharmacies in the psychiatry and neurology

Generic companies are paying with


fewer margins than innovators.
Therefore, the structure of a
company like toLife needs to be
different because it does not have the
same spending ability as a
multinational with originators.
areas, toLife moved onto other areas. In general, I try to find products that really allow
the company to create a relation with our
partners, doctors, pharmacists, and patients.

PB: Upon reflection, what has been most


important to you, having created and grown
toLife from scratch?
FRANCISCO VELEZ: It is very rewarding to start
a project from zero and ten years later,
despite extremely difficult conditions with
strong competition, see consistent and continued future growth. Since 2011 until the
present, toLife has been one of the fastest
growing companies in units and value in the
total Portuguese market. The company is
number five in the generic market, but is also
in the top 25 for the total market. However,
this success cannot be attributed to the job
of one person. I am very grateful to all my
people who have contributed to this. While
one person manages the people, the results
have been generated from the people I was
lucky to find who understood and embraced
the company philosophy; it will be a continuous challenge to me.

PORTUGAL APRIL 2014

42

Interview with: Joo Lobo Antunes, Founder - Institute of Molecular Medicine (IMM)

INTERVIEW WITH:

Joo Lobo Antunes, Founder Institute of Molecular Medicine (IMM)


PharmaBoardroom: Could you please introduce
yourself to our readers?
JOO LOBO ANTUNES: I am a professor of neurosurgery. I was trained in the US, where I
stayed for many years until I returned to
Portugal to be chairman of the department
of Neurosurgery at the University of Lisbon.
I worked at the New YorkPresbyterian
Hospital followed by several jobs and positions including president of the National
Council for Science, Technology and Innovation a few years ago. I created IMM in
2001 out of different laboratories from the
University of Lisbons medical school. IMM
has an outstanding group of nearly 500 scientists working there. With 100 PhD students as well, our scientific output has
increased dramatically. I am also the Chairman of the Board of Trustees of the agency
to evaluate higher education in Portugal.
PB: How would you rate Portugals scientific
output nationwide?
JOO LOBO ANTUNES: The scientific development of the country just passed its infancy.
This growth started when Mariano Gago
became the Minister of Science in 2005. I
was a member of the original panel to evaluate scientific programs in different Portuguese institutions, and the first step was to
send a number of Portuguese students to
get their PhDs to various locations in
Europe and USA. They then came back, and
we established priorities to be competitive,
particularly in the European context. For
example, a research group studying malaria

here just received a grant of almost $1 million from the Bill and Melinda Gates Foundation.

PB: You mentioned in your 2012 annual


report that Portugal was experiencing a
brain gain.
JOO LOBO ANTUNES: In times of economic crisis, the tone tends to be overly pessimistic.
We are finally starting to see some signs of
recovery. Many have discussed brain drain
in relation to people leaving the country
and so forth. It is true that some who went
to study abroad never came back for career
or family reasons. I am not worried about
brain drain because the quality of institutes
like IMM, Gulbenkian and Champalimaud
are enough to attract researchers to Portugal. We can offer the proper ecosystem.
There is already a critical mass that allows
Portugal to be competitive in that regard.
PB: Could you describe IMMs efforts in
research?
JOO LOBO ANTUNES: IMM started as a basic
science institute in areas like cell biology,
infection and immunity. We had to be qualified enough in these areas before we
opened up to clinicians. Slowly, we have had
clinicians come to IMM with their own
projects because we are very close to the
biggest university hospital in the country.
Two years ago, we created an Academic
Medical Center that has created an influx
of medical students, medical specialists,
and specialists in training. Now we have

Joo Lobo Antunes, FOUNDER - INSTITUTE OF MOLECULAR MEDICINE (IMM)


PORTUGAL APRIL 2014

43

clinical groups established in IMM in immunology, rheumatoid arthritis, neuroscience,


and oncology. We also created BioBank, which
has grown immensely and is connected to a
network of international BioBanks, so we supply samples to a number of countries for specific research problems like brain tumors,
rheumatoid diseases, dementia and movement disorders. We have the ability to supply
biological material with detailed clinical
information.

PB: What defines IMMs entrepreneurial spirit


in turning science into commerce?
JOO LOBO ANTUNES: We started with basic scientists. The culture of the entrepreneur is not
natural in them. With our current dimension
and scale, we are patenting more; in 2013 we
had six patents. IMM is now effectively integrated into Portugals biggest university,
which has created many synergies with Instituto Superior Tcnico.
PB: To what extent does IMM collaborate with
researched-based pharmaceutical companies
here?
JOO LOBO ANTUNES: We would like to cooperate
more. We have had visits from companies like
GSK and Pfizer, and they can distinguish our
enthusiasm. Pharmaceutical companies that
come to IMM are trained to recognize quality
and they immediately understand how bright
our researchers are.
With BioBank, some pharmaceutical companies want access to our samples. More and
more we aim for personalized medicine. We
also have a very sophisticated diagnostic laboratory, GenoMed, which focuses on genetics
and biological diagnosis of diseases. Other
kinds of partnerships are serviced. A laboratory like GenoMed is no longer a mere diagnostic service but also supports independent
research projects. That can make a huge dif-

Interaction of industry and sciences


is the key. I call these business
alliances the fourth dimension of
university
ference to pharmaceutical companies. Many
companies outsource research to laboratories,
some of which are connected to universities,
others independent, which can perform the
necessary research to implement medications
and drugs. Interaction of industry and sciences is the key. I call these business alliances
the fourth dimension of university, which
again has some risks. Universities in the marketplace and their cooperation with industry
should not limit academic research to fulfill
its goals of traditional science.
You have had a long and distinguished career
throughout your lifetime. What advice would
you give to a young researcher today?
JOO LOBO ANTUNES: You have to work and
work, and do so in the right environment. I
still do almost 400 operations a year. Of
course if you do not have the necessary tools
it is hard, since science is tool-driven rather
than concept-driven. The country already has
the proper ecosystem to develop a scientific
culture and mode of thinking. The rest is talent and hard work.
What are your ambitions for the future?
JOO LOBO ANTUNES: I hope that IMM becomes
more international and has more partnerships with industry. I hope we have more PhDs
in the industry too. I hope universities as
institutions of learning are more in tune to
the needs of science and society and I hope
they obtain more capital that is distributed
properly to get out of this crisis. We must fight
for this.

PORTUGAL APRIL 2014

44

Interview with: Jos Albino Mendes, General Manager - Servier Portugal

INTERVIEW WITH:

Jos Albino Mendes, General


Manager - Servier Portugal
PharmaBoardroom: You have managed Servier Portugal for ten years. From your perspective, could you describe the evolution
of the industry?
JOS ALBINO MENDES: At the beginning of
the decade, a number of synergistic measures were implemented to deal with Portugals looming economic woes. 2006 and
2007 were the pinnacle years, as the
industry saw the support of generics,
restrictions on prescriptions, pricing cuts
of six percent twice as an administrative
measure, and a constantly evolving reference pricing system. These economic measures created a loss of value in price and
medicines. In parallel, the commercial
chain entered into financial difficulties
due to decreased consumption. In the last
four years, these measures were reinforced with even more measures, such as
international nonproprietary name (INN)
prescriptions controlling commercial
brands. In parallel this created prescription control. Simultaneously, many incentives were implemented at the pharmacy
level to switch to generics, which were
very important to create switch dynamics
in pharmacies. There is more transparency too; we are now obliged to communicate all our promotional activities and
sponsors to doctors and INFARMED.
PB: What measures did you personally take
to adapt to these changes?
JOS ALBINO MENDES: In our company culture, we do not prioritize downsizing
despite its easiness. Instead, I tried to

Jos Albino Mendes, GENERAL MANAGER - SERVIER PORTUGAL


PORTUGAL APRIL 2014

rationalize the best measures to reduce


other expenses. Promotional activities
were more focused, the company redefined targets and regions where we could
maintain a solid level of activity, and we
redistributed our sales force according to
its potential.

PB: How has the Portuguese governments


push to adopt generics affected this affiliates strategy?
JOS ALBINO MENDES: We can use generics
as an open door to innovation if implemented properly. However, I think there
is an imbalance between generic policy
and support for innovation in that generics are communicated too much as a priority. Innovation and generics need equal
attention and support; otherwise only old
products not adapted to new challenges
will be available to the ageing population.
PB: How is Serviers portfolio represented
in Portugal?
JOS ALBINO MENDES: Servier is a leader in
a number of cardiovascular prescriptions
in Portugal. The organization is strongly
recognized in this indication in Portugal,
such as coronary artery disease, heart
failure, hypertension, and vascular diseases. Servier is also a market leader for
sulfonylurea, and has more than 50 percent market share in chronic venous disease. The company also has a strong focus
on antidepressants, osteoporosis, and is
beginning research in oncology. Additionally, while Servier does have old products

45

mixed with generics, the company is compensating for loss of exclusivity with a number of new, innovative products in Portugal.

The quality of our work in the industry


could provide a way to create and export
ideas.

PB: Servier invests 25 percent of its turnover


in R&D, higher than the industry average.
How is that investment reflected in Portugal?
JOS ALBINO MENDES: During the throes of
Portugals economic crisis, this subsidiary
actually created an international center for
research, with ten individuals conducting
several studies across Portugal for old and
new products. This research center was created as a symbol and a demonstration to
doctors, authorities and internal collaborators that the company is truly investing in
Portugal, and is here to stay not just to sell
medicines but to also be a strategic partner.
Servier is ahead of the curve for R&D in the
pharma industry.

PB: What would you like to achieve in the


next five years?
JOS ALBINO MENDES: Today, Servier is ranked
sixth in Portugal. We were ranked third five
years ago, and the first among European
companies. I think we deserve to regain this
position among the top five. Some newly
launched products will help to make it to
the top three again. Our research center can
be much more important in projects, especially with the arrival of new oncology products, and can help to gain a new dimension
for research in this country.

PB: What is the strategic importance of Servier Portugal in relation to the entire organization?
JOS ALBINO MENDES: Six years ago, this subsidiary was ranked the fourth most important in the entire Servier network, which is
impressive given Portugals size. Servier
was also the only company in Portugal with
three products among the top ten in the
total pharmaceutical market. This subsidiary therefore has a strong responsibility to
the group not only in terms of volume of
commercial business, but also as a symbol
of being able to launch our products in a
strategic manner in a small market with difficult conditions. We have to maintain that
symbol. Between 2005 and 2007, Servier
was the Best Pharmaceutical Company in
Portugal. This affiliate is like a school for
entrepreneurship, and demonstrates the
potential of Portugal for all stakeholders.

PB: What advice would you give to other general managers in the midst of a crisis?
JOS ALBINO MENDES: I have crisis experience
from working in Brazil, Argentina, and now
Portugal. All these crises are simply cycles.
The pharmaceutical market and companies
must stay in their countries, adapting their
conditions to these cycles. Crises teach you
how to do better with less resources, how to
focus on priorities, deal with adversity, find
new ways of working, and motivate teams in
difficult conditions. It is very interesting for
management and international companies
because they can not only succeed in difficult
conditions but also be part of what I call the
exporting experience: sharing their learning about new ideas of working with other in
the industry. I am optimistic because these
difficulties provide opportunities to create
innovative solutions. As in Chinese, the word
crisis also means opportunity.

PORTUGAL APRIL 2014

46

Interview with: Marta Ferreira, General Manager - Inovapotek

INTERVIEW WITH:

Marta Ferreira, General Manager Inovapotek


PharmaBoardroom: Could you explain the
creation of Inovapotek?
MARTA FERREIRA: Inovapotek is a spinoff
of the Faculty of Pharmacy at the University of Porto, where my partner and I were
previously researchers. Having worked on
a project there that combined industry
and academia, I realized that much of the
knowledge developed at the University
was not being properly implemented. The
challenge then was to use the experience
we had to service the pharmaceutical and
cosmetics industries. Since then, the company was established with a vision to promote the development of innovative
products that comply with regulatory
specificities and consumer demand. Many
academic projects are not focused on the
market and do not take existing regulatory restrictions into account. Thus, our
focus has been to exploit our knowledge
to focus on the market needs.
PB: What is your vision of the research
environment and its challenges?
MARTA FERREIRA: Portugal has incredible
researchers and R&D for life sciences.
Society in Portugal is starting to realize
that there needs to be more emphasis on
the market and more attention paid to
industry, but there are still many boundaries. A generation of young and wellqualified researchers without boundaries
is now on the market given their international experience, but many times fail
because they coexist with another more
close-minded and uncooperative genera-

Marta Ferreira, GENERAL MANAGER - INOVAPOTEK


PORTUGAL APRIL 2014

tion. These boundaries cannot continue.


When I started on this bridge between
academia and industry ten years ago, it
lacked structure. This is starting to
improve. Universities have been dedicating time to this, as seen with science
parks, innovation centers, and supported
infrastructure. Still, many people struggle to orient research properly because of
that lack of regulatory awareness or focus
on the market. Inovapotek has been
working on many projects regarding this.
As a bridge between academia and industry, we help all parties understand each
other. Inovapotek helps with R&D management, project monitoring and regulatory compliance.

PB: What do you think needs to be improved


in terms of regulatory affairs?
MARTA FERREIRA: We need more harmonization among the European Union. Life
science involves different regulations
depending on the type of products. Medicines, food supplements, medical devices
and cosmetics all have different regulations. Even though European regulations
intend to harmonize legislation across
the different member states, there are
often many grey areas that are not interpreted and applied equally by the national
authorities of each different member
state. This creates barriers and sometimes
makes Portuguese companies experience
more difficulties in placing products on
the market that in other member states
and this should not happen. The origin of

47

the problem is the lack of harmonization


and clarification of grey areas on the regulation.

PB: How do you reach out to your customers?


MARTA FERREIRA: Inovatpotek has always maintained an international spirit. Portugal has
potential, but today we cannot think solely in
terms of domestic markets. As such, we
designed our first international plan in 2009,
and participated in our first international
exhibition in Paris in 2010. That was the first
year that Inovapotek began to promote itself
abroad. Since then, we have attended one or
two international exhibitions per year.
Inovapotek is established in 13 markets, primarily in the US and Europe but also on countries like South Africa and South Korea. 60
percent of sales come from abroad. We have
grown a lot from our work and scientific
approach; we have a very high percentage of
fidelization of clients. In the next five years
also focus on Middle East, South America, and
Asia.
PB: What are the similarities and differences
between personal and pharmaceutical products?
MARTA FERREIRA: In personal care, we work in
all stages of product development, including
formulation development, quality control,
stability studies, efficacy and safety studies,
and regulatory affairs, preparing all documents for the product to be ready to market.
We cover the entire chain and we uphold consulting activities in this area. In the pharmaceutical area, we primarily work in formulation; either with classic formulations or
improvements of classical formulations. As
regulatory restrictions become severe, many
products have to be reformulated in order to
accomplish these stricter rules. We have spent
much of our effort on these kinds of projects.

We also develop new drug delivery systems,


which are one of Inovapoteks specialties; laboratories are now using proteins and gene
therapy as new therapeutic agents, and they
need new drug delivery systems for administration. We also cover pharmaceutical quality
control.

PB: What is the potential of the manufacturing


sector and how can it contribute to Portugals
growth?
MARTA FERREIRA: Manufacturing can contribute and grow the economy, but this must come
from knowledge-based growth. It needs to
have a very well-designed strategy focused on
niche markets because the Portuguese environment has many highly-qualified people
and is very attractive for foreign investment
and employment. All the research organizations and knowledge that exist in this region
are interesting as well. My opinion is that
manufacturing must employ a very welldesigned strategy that looks at other players
and other countries, finding our specific
niches to develop.
PB: How do you see Inovapotek developing in
the next five years?
MARTA FERREIRA: Inovapotek is still in expansion stage so we will surely continue to grow
quickly in the next five years. In previous
years we worked more in personal care for
international business, but now we will focus
more effort to expand the pharmaceutical and
food supplements areas. I also believe that in
personal care, we will accomplish our goal of
becoming a completely global company, with
presence in the Middle East, South America
and Asia. In five years we will have more local
agents in global regions working in personal
care and in pharmaceuticals and food supplements, we will start the internationalization
process in Europe and then the US.

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48

Interview with: Miguel Lopes da Cunha, CEO - FAPOMED SA

INTERVIEW WITH:

Miguel Lopes da Cunha, CEO FAPOMED SA


PharmaBoardroom: Why does the overlap
between pharmaceuticals and medical
devices exist?
MIGUEL LOPES DA CUNHA: This overlap is logical, as we are all focused on offering assistance, working with chemicals, innovating,
developing new materials and providing
new protection. With medical devices, we
try to keep the environment of operation
theaters safe by avoiding chemicals to guarantee physical protection. We are becoming
more efficient as bacteria also become more
efficient. This sector is based on research,
materials and investments. Innovation is
cheaper than in the pharmaceutical industry and takes less time to be implemented.
PB: We have seen that Fapomed is a founding
member of the Medical Device and Pharmaceutical Group. What does this group
hope to achieve?
MIGUEL LOPES DA CUNHA: This group aims to
attract attention to and lobby for the Portuguese healthcare industry and to make
use of the expertise of each company in
order to create synergies of know-how
between the medical device and pharmaceutical sectors. We recently attended the
business forum Medicines and Health
Products, organized by the Institute for the
Promotion and Development of Latin
America, and we formed a mixed group of
companies to be present in several South
American countries, represented by their
ambassadors. This improves communication and economic relations between these
regions.

Miguel Lopes da Cunha, CEO - FAPOMED SA


PORTUGAL APRIL 2014

PB: What measures did you take to adapt


after Portugals crisis started?
MIGUEL LOPES DA CUNHA: We were impacted
by the price cuts and pushed harder towards
regaining the market quota and finding
more business. We were exposed to price
reduction pressures of 15 percent but did
not have the margin for it. There are medical devices with high margins, but in nonwoven medical devices there is fierce competition from the Far East, given their
strength in hand labor. Furthermore, Portugal does not have flexible labor legislation.
Fapomed now exports to more than 20
countries and at the end of 2013 we achieved
the same sales volume as 2012 but with a
better sales return. In 2009 we expanded
activities to Eastern Europe by establishing
a manufacturing unit in Ukraine, anticipating the markets future. We started by
reducing the stocks, shortened the supply
chain and became more flexible.
PB: What advantages has this brought in
terms of being competitive overseas?
MIGUEL LOPES DA CUNHA: Our scope was to
reduce the risks associated with the crisis
and the competitive prices coming from
Asia. With solid capacity and technology to
manufacture and innovate, Fapomed provides the opportunity multinational customers need to reduce future environmental risks, long supply chains and lack of
flexibility, all of which are associated with
Asian markets.

49

PB: Do you believe that the manufacturing sector could be a new engine of growth in Portugal?
MIGUEL LOPES DA CUNHA: There are a few good
medical device manufacturers in Europe, but
the number is dwindling. This has influenced
plans to re-industrialize Europe. A recent
European Commission report stated that foreign investment in Europe has dropped from
40 to 20 percent over the last decade. We are
moving factories to other regions, which has
resulted in job and capital losses. We must
refocus on creating more jobs and exports.
Portugal has the technology, people, universities and know-how at reasonable costs; but
Portugal needs to promote itself more. We
must also provide jobs to young people; our
law is not protecting the jobless. We need to
readapt companies and take risks. Industry
and entrepreneurs in Portugal like to take
risks, push for sales and are able to adapt easily to new territories.
PB: What exactly is your target market?
MIGUEL LOPES DA CUNHA: Ukraine facilitates
access to new regions like Russia and Eastern
Europe. But we also ship to Chile, for example,
and we have not reduced our manufacturing
capacity in Portugal. We have started to think
globally and to take chances. Conversely, we
are improving our brand image and promoting our own brands now. We manufacture inhouse more than 50 percent of our products
contents and simultaneously we have acquired
know-how in other relevant components comprised in our whole kits. We want to start
manufacturing in countries willing to progress technologically, where we will develop
and design a top product according to their
needs. Our potential markets are the PALOPs
and Eastern Europe.

universities and companies for research and


innovation?
MIGUEL LOPES DA CUNHA: Working with universities in research is cost-effective. Since the
company started, we have worked together
with universities, sharing know-how and
available testing apparatus, and have created
as many partnerships as possible. We are currently involved in several projects in collaboration with universities and research centers,
one of which involves new European regulations and designing the requirements of a new
clean air suit.

PB: What makes Fapomed the partner of choice


in this niche market?
MIGUEL LOPES DA CUNHA: Fapomed has experience and know-how, and enjoys a solid reputation among the most important suppliers
in the business through proximity and ease
of communication. Multinationals rely upon
us for many validation processes, and other
specialized tasks since our technicians and
our laboratories are reliable and cost effective.
PB: What will be the main growth drivers of
Fapomed for 2014?
MIGUEL LOPES DA CUNHA: Exports will continue
to play an important role in Fapomeds
growth. We are looking at Eastern Europe and
we hope to boost sales in the North African
market, an area where we have been investing
for several years and the conditions are more
favorable now. We must also regain and consolidate a bigger share of the Portuguese market, and find strategic partnerships with companies that complement our expertise.
Medical devices aimed to newborn and pediatric market in countries with a high birth
rate are also on our list for strategic developments.

PB: How effective is the relationship between

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50

Interview with: Pedro Merlini, Country Manager - Aurobindo Portugal

INTERVIEW WITH:

Pedro Merlini, Country Manager Aurobindo Portugal


PharmaBoardroom: What factors have lead
to the instability surrounding generic
drugs in the Portuguese market?
PEDRO MERLINI: For 20 years, the lack of
generic regulation in the country lead to
a market of copy products that avoided
problems inherent to the generic business. In 2002, the introduction of a
generic market in Portugal created many
changes. However, compared to other
European countries, Portugal still needs
to develop this market. Understanding
the concept and implications of generic
market takes time, and in that sense Portugal is still not a mature state yet.
While a new methodology for patent
issues was recently implemented in
court, I do not think it is working as well
as it could.
PB: What kinds of specific improvements
need to be made?
PEDRO MERLINI: Companies need to know
exactly when an originator is launched,
registered, when changes are made to its
indication, and when its patent protection ends. Nonetheless, companies continuously violate patents and launch
products, which kill originators and
leads to greater problems in the future.
Patent violation should be strongly reprimanded. If patent infringement jeopardizes originators business, it will completely spoil the future of the generic
market, and will damage patients and
the system.

Pedro Merlini, COUNTRY MANAGER - AUROBINDO PORTUGAL


PORTUGAL APRIL 2014

PB: You established this affiliate in May


2010; what were your initial objectives
for Aurobindo Portugal?
PEDRO MERLINI: I started here almost two
years after the price cuts lead to the pharmaceutical crisis. The objective was to
build a structure and to launch the brand
in the Portuguese market, which was difficult in a declining environment, mainly
because the rules for establishing prices
are defined by the government; the last
company to enter has the lowest price. I
had a relatively limited number of products to start, and with these conditions I
did not have much room for maneuver. The
majority of generic companies are almost
completely oriented to the pharmacy channel, providing discounts and bonuses. My
prices were so low, I could not compete. I
adopted a strategy abandoned by everybody, which was to focus on medical prescription. In an environment where the
business is more focused on channels than
prescriptions, I decided to orient Aurobindos strategy towards medical promotion,
given our late arrival in the market. In
doing so, I had to invest in top-quality
salespeople and technology, which are
both very important in any business, but
are also very costly. I bet almost everything on these two resources. It was a huge
investment because we needed to develop
our communication, CRM and market
information in digital formats.
Before starting this business, I had
already expended a huge amount of capital. The perspective was not bright, being

51

the last company with the lowest prices in


the market. But those low prices will be
needed in the future, and I wanted Aurobindo
to be the company that creates awareness of
this necessity. We started to explain the company and strategy to medical doctors, and
how they would need to use the lowest priced
products to afford money for the state, and
to reimburse high price R&D products using
low price generics. This strategy allowed
medical doctors to look at Aurobindo in a different way compared to other companies providing countless discounts and bonuses to
pharmacies. We are giving doctors a reason
to use the cheapest products that will allow
them to truly benefit patients and the state.
This unique approach is starting to provide
some results. This strategy will work in Portugal only because of our strong investments
in people and technology. With the lowest
priced products in the market, we must have
the lowest manufacturing cost of goods. The
strategy itself is not brilliant, but it can work.
95 percent of companies operating in the
Portuguese market do not have the opportunity to use such a strategy because the cost
of production will not allow it.

PB: In January 2014, Aurobindo purchased


the commercial operations of Actavis in Western Europe. What impact will this transaction have in Portugal?
PEDRO MERLINI: Actavis is already one of the
top ten generic companies in Portugal, and
has a strong brand that is respected here.
Portugal still prioritizes brands at the level
of pharmacists, prescribers and patients,
despite the increase in generic use over the
last decade. This acquisition will create big
changes for Aurobindo because Actavis
already has critical mass in Portugal, which
we need. Aurobindo has actually been the
fastest growing company in the total Portu-

In an environment where the


business is more focused on channels
than prescriptions, I decided to
orient Aurobindos strategy towards
medical promotion, given our late
arrival in the market.
guese pharmaceutical market for the last 16
months, but that is because we started from
zero. Nevertheless, it provides an important
indication of consistent growth. While there
is still much work to be done, Actavis will
provide immediate access to 100 molecules
in addition to the 42 Aurobindo has, accelerating our pace of growth.

PB: What is the strategic importance of


Aurobindo Portugal in relation to the entire
organization?
PEDRO MERLINI: Aurobindo Portugal is important within Europe, since there are only a few
affiliates on this continent. Worldwide, Portugal is small. But Aurobindo is only present
in a handful of countries, and thus Portugal
becomes much more important than the traditional 0.5 percent that this country usually
represents to the worldwide turnover of a
pharmaceutical company, or any company.
PB: What is your vision for the next five years?
PEDRO MERLINI: The next six months will be
vital for merging the operations of Actavis.
In five years I would like to be among the ten
biggest generic companies in Portugal. Today,
Aurobindo is ranked 22nd, and we will be in
the top twenty very soon. The Actavis acquisition will most likely place Aurobindo
among the top ten.

PORTUGAL APRIL 2014

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53

Company index
AICEP .................................................... 22, 24

IMS ..........................................................7, 20

Almirall ....................................................2, 11

INFARMED 7......... , 9,12, 16, 32, 34, 36, 41, 44

Amgen ................................................... 12, 19

Inovapotek ............................................ 46, 47

Apifarma ................................... 7, 9, 28, 29, 38

Jaba Recordati 17, 20

Apogen ....................................................... 12

Janssen ..................................7, 11, 12, 20, 38

Aurobindo ........................................14, 50, 51


Bayer .................................................. 9, 11, 20
Bene Farmacutica ................................... 14
Bial ........................................................ 16, 20
Bill and Melinda Gates Foundation ........... 42
BioBank ...................................................... 43
Biopremier .................................................. 23

Jornal de Negcios .................................... 35


Labesfal ..................................................... 18
Lagoas Park ............................................... 13
LEO Farmacuticos ................................... 14
Ministry of Economy ..............18, 19, 24, 25, 38
Ministry of Health ............. 7, 14, 26, 28, 34, 38

BMS ............................................................ 14

Mylan .......................................................... 13

Celgene ...................................................... 19

National Platform for Clinical Research .. 11

Cell2B ......................................... 20, 21, 36, 37

National Statistical Institute of Portugal.. 18

Central European Bank .........................7, 28

New York-Presbyterian Hospital ............... 42

Champalimaud ........................................... 42

Novartis ............................................13, 15, 20

Ciclum-Stada ........................................ 12, 13

OCP Portugal ........................................ 10, 11

EMA ....................................................... 11, 37

Octapharma ........................................... 32, 33

Esteve .................................................... 12, 40

P-BIO ................................................20, 21, 37

European Commission ......................... 28, 49


Fapomed ............................................... 48, 49
FARMED ..................................................... 10
FDA ............................................................ 16
Formifarma ................................................. 21
Fresenius Kabi ....................................... 17, 18
Generis .................................................. 12, 20

Pfizer ..................................................... 20, 43


Portuguese Central Ethics Committee...... 11
Roche ......................................................... 10
Servier ....................................... 14, 20, 44, 45
Technical University of Lisbon ................. 37
Technophage ............................................. 17

GenoMed .................................................... 43

Tecnifar .................................................. 16, 17

GSK .....................................7, 8, 20, 38, 39, 43

Tecnimede ............................................. 14, 16

Gulbenkian Health Cluster Portugal ....... 42

toLife..................................................12, 40, 41

Iberfar ................................................... 16, 18

University of Lisbon .................................. 42

IMF ..................................................6, 7, 27, 28

University of Porto ................................... 46


PORTUGAL APRIL 2014

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PORTUGAL APRIL 2014