Professional Documents
Culture Documents
LIFE SCIENCES
REVIEW
&
PHARMACEUTICALS:
SHAKING UP THE SYSTEM
PAGE 21
A TIMELINE OF REFORMS
PAGE 8
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
PORTUGAL
2013
April 2014
PTCOR0130_Fev2014
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
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
PORTUGAL:
april 2014
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portugal report
A TIMELINE OF REFORMS
2007
2008
2009
2010
2012
(Jan.)
(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.)
(Aug.)
6% Mandatory Discount in Retail Price for all reimbursed medicines - Ordinance n 1041-A/2010
(Oct.)
(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.)
DO
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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.
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Special SponSored Section
Veronique
France
Mylan Senior Plant Director
I can
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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
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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.
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Jos Albino
Mendes, General
Manager, Servier
Portugal
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
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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
LOOKING TO THE
FUTURE.
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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
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
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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
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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.
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*
2008
2009
2010
2011
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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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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.
MSD
Novartis
Pfizer
Bial
AstraZeneca
Servier
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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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MEdiCAL dEviCES
HEALTHCARE
Employment: 6,196
Employment: 4,573
Employment: 247,630
Increasing rate
in the last 5 years: + 24.3%
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
24
INTERVIEW WITH:
Pedro Gonalves, SECRETARY OF STATE FOR INNOVATION, INVESTMENT AND COMPETITIVENESS - MINISTRY OF ECONOMY O
PORTUGAL APRIL 2014
25
OF PORTUGAL
PORTUGAL APRIL 2014
Interview with: Manuel Teixeira, Secetary of State for Health Ministry of Health of Portugal
26
INTERVIEW WITH:
27
28
INTERVIEW WITH:
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
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.
30
INTERVIEW WITH:
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.
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.
32
INTERVIEW WITH:
KEDRION PORTUGAL
33
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.
34
INTERVIEW WITH:
35
generics to balance out the system, in addition to being a sustainable partner in our
OTC division, which is not reliant on reimbursement.
36
INTERVIEW WITH:
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.
38
INTERVIEW WITH:
39
40
INTERVIEW WITH:
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
42
Interview with: Joo Lobo Antunes, Founder - Institute of Molecular Medicine (IMM)
INTERVIEW WITH:
here just received a grant of almost $1 million from the Bill and Melinda Gates Foundation.
43
44
INTERVIEW WITH:
45
mixed with generics, the company is compensating for loss of exclusivity with a number of new, innovative products in Portugal.
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.
46
INTERVIEW WITH:
47
48
INTERVIEW WITH:
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.
50
INTERVIEW WITH:
51
52
53
Company index
AICEP .................................................... 22, 24
IMS ..........................................................7, 20
Almirall ....................................................2, 11
Apogen ....................................................... 12
BMS ............................................................ 14
Mylan .......................................................... 13
Celgene ...................................................... 19
Champalimaud ........................................... 42
GenoMed .................................................... 43
toLife..................................................12, 40, 41
54