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INITIATING A SMART
HEALTHCARE
REVOLUTION
PAGE 10
TRAILBLAZER OF
EMERGENCY
HEALTHCARE
PAGE 12
THE FLOURISHING
MEDICAL DEVICE
MARKET
PAGE 38
VIBRANT CLINICAL
TRIALS MARKET
PAGE 46
COVER STORY
WHERE
CREATIVITY
BRINGS
PROFITABILITY
page 18
ROMANIA
DECEMBER 2015
Acknowledgements
PharmaBoardroom is profoundly grateful to
Nicolae Bănicioiu, Minister of Health
Raed Arafat, Secretary of State at Ministry of Interior
Roberto Musneci, Managing Partner at SMA
Gabor Staniszlav, Country Manager at Amgen
Torge Doru, Managing Director at Ferring
George Cretu, Founder of Enterprise Concept
alongside the many other stakeholders we have met for their
steadfast support, encouragement and enthusiasm.
Initiating
a“Smart
healthcare”
revolution
Interview 10
HEALTHCARE & LIFE SCIENCES
REVIEW ROMANIA
CONTENTS
—December 2015
2
Acknowledgements
7
PREFACE Romania
5
8
Romania —where
creativity brings profitability
Cover story 18
Foreword
ROMANIA IN FIGURES Overview / Pharmaceuticals
10 THE DOCTOR HEALING ROMANIA’S HEALTHCARE
SYSTEM INTERVIEW INTERVIEW Nicolae Bănicioiu,
Minister of Health
12 MAN WITH A MISSION INTERVIEW Raed Arafat, Ministry
of Internal Affairs
14 SEARCH FOR A ROMANIAN MODEL FEATURE Private healthcare
16 A FERTILE SECTOR FEATURE Fertility treatment
17 THE MARKET FOR ADVICE AND ADVISERS FEATURE Consultancies and law firms in Romania
18 ROMANIA — WHERE CREATIVITY BRINGS
PROFITABILITY COVER STORY 20 Ushering in the brave new world of Romanian healthcare
22 Practical strategies for generating profits in a hostile
regulatory climate
Rewiring
the system
Interview 32
21 Low down on an avalanche of reforms
23 Untangling the gordian knot of chronic underspending
24 Navigating a complex operational environment
25 Back to the future: reprioritizing brand building
27 Mobilizing a “coaliţia” for combined progress
28 Contract manufacturing prowess
29 The Indian connection
30 Voices from the inside
31 On the brink of a tipping point...
32 INSTITUTIONAL INNOVATOR INTERVIEW Vasile Ciurchea, National Health Insurance House (CNAS)
34 SAFETY AND INNOVATION THROUGH BETTER
REGULATION INTERVIEW Dr Marius Savu, NAMMD
This edition of Healhcare & Life Sciences Review was produced
by Focus Reports.
Project Director: Louis Haynes
Project Coordinator: Valerie Baia
Project Assistants: Zachary Burnside, Angelo Basurto
Report Publisher: Mariuca Georgescu
Graphic design: Carmen Reyes
For exclusive interviews and more info, please log onto
www.pharmaboardroom.com or write to contact@focusreports.net.
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 forerrors and omissions. Opinions expressed in this report are not necessarily
those of the authors.
www.pharmaboardroom.com
36 SPECIALITY CARE BIO-PHARMA INTERVIEW
Călin Gălăşeanu, Country Manager of Bristol-Myers Squibb
38 AN UP AND COMING SECTOR FEATURE The medical
device market
39 CONSOLIDATION, ACQUISITIONS, AND CHANGE FEATURE Pharmacies in Romania
40 READY TO SPECIALIZE INTERVIEW Vijay Palamadai,
Dr Reddy’s
42 MYLAN: EXPERIENCE AND INNOVATION INTERVIEW Adrian Grecu, Mylan
44 ROMANIAN LEGAL PIONEER INTERVIEW
Gheorge Muşat, Managing Partner of Muşat & Asociaţii
46 EFFICIENCY, SPEED AND OPPORTUNITY FEATURE Clinical trials in Romania
Healthcare & Life Sciences Review: Romania
3
As President of the National Agency for Medicines and Medical Devices (NAMMD),
I am proud to introduce this one-off report on the local pharmaceutical and healthcare
sector. This affords a unique opportunity and effective communication platform to
demonstrate the capabilities of the industry and its actors here in Romania.
Over the past years, Romania, now the largest pharmaceutical market in South East
Europe and soon to rank 3rd largest across the CEE, has been building up its pharma
industry and is undergoing continual improvements to its healthcare system to the benefit
of the entire nation.
One area where we have been making particular strides has been in the country’s
regulatory landscape. Acting as competent authority in the field of medicinal products for
human use, as regards marketing authorization and surveillance of the safety of medicinal
products, the NAMMD continues to strengthen its status as a reference national authority
and has been boosting its capabilities both as guarantor of public health and as an expert
and reliable source of accurate and timely information.
With this special report on the industry, I invite all members of the pharmaceutical and
healthcare communities to take a closer look to Romania’s dynamism and what it has to
offer.
Warm Regards,
Dr Marius Savu
President of the National Agency for Medicines and Medical Devices (NAMMD)
STRAP IN HERE PLEASE
Strap subhead in here please
6
PREFACE
Romania
Preface
This report captures Romania as it emerges from a challenging period. After years of recession the country has seen a return to growth,
and the European Commission now predicts four percent growth
year on year for the three years to 2018. The Romanian healthcare system faces significant hurdles too, but is undergoing a period of reform and rationalization. The pharmaceuticals sector faces
longstanding regulatory challenges, but is showing a healthy rate
of growth.
The public healthcare system faces an exodus of medical talent and
a low rate of spending compared to the European average. However
there is progress on other fronts: today it is expanding, rationalizing,
and innovating. In this report, Minister of Health Nicolae Bănicioiu
explains how his department is modernizing the system and putting
it on a more financially sustainable footing, with the reopening of 26
hospitals, 3,500 new jobs, and newly subsided medicines becoming
available publicly. There is institutional reform too: Vasili Ciurchea,
president of the National Health Insurance House, discusses the new
national health smart card being rolled out to reduce waste, fraud and
inefficiencies.
The Romanian market for pharmaceuticals is still subject to an
erratic clawback tax and price controls, but despite this, it is growing.
While the perception is that Western European markets have reached
a plateau, Romania’s expanded by 7% in 2014, and has plenty of
potential for further growth: per capita consumption is just 12% of
the Western European average, and average income is going up 6%
a year. There is potential for further growth in state spending too:
the Romanian state spends under half of the OECD average as a percentage of GDP (4% compared to 8.9%). As Bogdan Savu, country
manager of Gerot Lannach puts it, Romania is “clearly an exciting
prospect where the ‘boom period’ is still waiting to happen.”
When it comes to contract manufacturing, the rest of the world is
also beginning to notice Romania’s structural advantages. It has highly skilled labour, wages are 30 to 40 percent of those in Germany, and
it is close to Western Europe - ideal for outsourcing manufacturing
for the rest of the European market. And in the EU market - with 27
different states and varying customization demands - Romania is a
particularly good location for last minute batch customization.
Our report also covers the clawback mechanism, the call to fund
new medicines, a growing private healthcare sector, the national debate on public healthcare spending, and the surprising lack
of generics penetration because of the Romanian cultural affinity
for brands.
The mood in the Romanian healthcare sector is of cautious
optimism about the years ahead. Dr Marius Savu, President of the
National Agency for Medicines and Medical Devices, tells us about
the embrace of smart technology and Romania’s “game-changing
innovations in healthcare.”
Cegedim Romania’s Petru Craciun says that although the healthcare system is ‘enduring growing pains’ there is hope for conclusive
progress. Recent reforms, a growing economy and significant structural advantages mean that Romania is set up well for a more prosperous, healthier future in the coming years.
7
ROMANIA IN FIGURES
Overview
HEALTHCARE SPENDING PERCENTAGE OF GDP
12
7%
5.94%
10.8
5.60%
5.29%
9.6
4.78%
5.16%
5.08%
5.44%
5.30%
5.21%
5%
8.4
Billion USD
6%
7.2
4%
6
3%
4.8
3.6
2%
2.4
1%
1.2
0%
0
FY10A
FY11A
Government health spending RON b
FY12A
FY13A
Private health spending RON b
19.9
14.5
Population
of Romania
Romanian over-18s eligible to use
the electronic healthcare card
SOURCE: WORLD BANK
SOURCE: ROMANIAN MINISTRY OF HEATH
6.8%
8.9%
Growth of
pharmaceuticals
market, 2014
Romanian
GDP spent on
healthcare
OECD average
GDP spent on
healthcare
SOURCE: CEGEDIM
SOURCE: WORLD BANK
SOURCE: OECD
USD
USD
FY16F
FY17F
USD
89.9
740.12
2.92
Romanian
annual spending
per head on
pharmaceuticals
EU average
annual spending
per head on
pharmaceuticals
Romanian
pharmaceutical
market
SOURCE: BMS
SOURCE: BMS
SOURCE: CEGEDIM
BILLION
FY18F
Source: Business Monitor International Romania
Pharmaceuticals & Healthcare Report Q4 2014.
TOP 10 ROMANIAN PHARMA
MANUFACTURERS BY TURNOVER
(2014)
TERAPIA S.A 1
MILLION
4%
FY15F
Health spending % of GDP
ROMANIA BY THE NUMBERS
MILLION
FY14B
117,359,862 USD
EUROPHARM S.A
2
96,024,758 USD
ZENTIVA S.A
3
88,760,293 USD
ANTIBIOTICE S.A
4
72,089,425 USD
SANDOZ S.A
5
69,216,157 USD
BIO EEL S.R.L
6
31,697,019 USD
LABORMED-PHARMA S.A
7
30,786,941 USD
BIOFARM S.A
8
28,944,951 USD
INFOMED FLUIDS
9
26,071,456 USD
GIDEON RICHTER
ROMANIA S.A
10
25,682,042 USD
Source: Cegedim.
8
ROMANIA IN FIGURES
Pharmaceuticals
ROMANIA LEADERBOARD
BY VALUE
1
2
3
4
5
6
7
8
9
10
CORPORATION
VALUES PPP
2014 Mill. USD
SANOFI Including Zentiva
HOFFMANN LA ROCHE
SERVIER Including Egis
NOVARTIS Including Sandoz
PFIZER
GLAXOSMITHKLINE Including Europharm
RANBAXY Including Terapia
ASTRAZENECA
MERCK & CO
KRKA
253
240.7
208.6
198.9
187.7
161.7
156.1
153.4
120
109
12
13
14
15
16
17
18
19
20
JOHNSON & JOHNSON
ABBVIE
MENARINI
TEVA
ANTIBIOTICE
BAYER
BRISTOL MYERS SQUIBB
ALVOGEN Including Labormed
ABBOTT
GEDEON RICHTER
1
2
3
4
5
6
7
8
9
10
92
89.1
86.5
78.8
76.9
75.6
73.5
70.4
60.7
56.7
11
12
13
14
15
16
17
18
19
20
2,549.3
TOTAL FIRST 20 SHOWN
UNITS 2014 CORPORATION
1,789.1
11
ROMANIA LEADERBOARD
BY VOLUME
Mill. Packs
SANOFI Including Zentiva
RANBAXY Including Terapia
SERVIER Including Egis
ALVOGEN Including Labormed
ANTIBIOTICE
GLAXOSMITHKLINE Including Europharm
NOVARTIS Including Sandoz
KRKA
GEDEON RICHTER
BIOFARM
61.2
48.0
32.8
30.2
29.0
26.0
25.4
23.0
20.1
19.3
315.1
PFIZER
MENARINI
RECKITT BENCKISER
ABBOTT
BAYER
ACTAVIS
ASTRAZENECA
TEVA
MERCK&CO
CSC PHARMACEUTICALS
12.9
12.8
10.8
10.2
9.0
8.2
7.3
6.3
6.3
5.0
403.9
Source: Cegedim.
EVOLUTION OF THE ROMANIAN PHARMACEUTICALS MARKET
BY VOLUME
BY VALUE
3.000
600
2.500
500
2.000
400
1.500
300
1.000
200
500
100
0
0
2005
Total Market
2006
2007
2008
2009
Retail - Rx - R&D Brands
2010
2011
Hospital Market
2012
2013
2014
Retail Market
2005
Retail - Rx
2006
2007
Retail - OTC
2008
2009
2010
Retail - Rx - Branded Gx
2011
2012
2013
2014
Retail - Rx - Un-branded Gx
Source: Cegedim.
9
THE DOCTOR HEALING ROMANIA’S
HEALTHCARE SYSTEM
INITIATING
A “SMART
HEALTHCARE”
REVOLUTION
HCLS talks to Nicolae Bănicioiu, Romanian Minister of Health about
implementing a national electronic card system to cut waste, expanding
the healthcare system while putting it on a sustainable footing, and how his
experience as a doctor gives him a unique point of view.
HCLS: What would you say have
been the main milestones achieved
since your nomination as Minister
back in March 2014?
Nicolae Bănicioiu: I think that we
achieved many milestones, as a team,
here at the Ministry within this short
time frame. We are talking about the
reopening of 26 hospitals, 3,500 new
jobs for the health system and, for the
first time in 7 years, a new list of subsided medicines including 40 new molecules covering important therapeutic areas such as diabetes, Cancer and
HIV/Aids.
Right now we are implementing the
national electronic card which represents another milestone for eliminating
wastage in the healthcare system and
for encouraging preventative healthcare. This should contribute considerable
monetary savings that will then be automatically reinvested back into medical system. From now on, the more than
14.5 million citizens, over 18 years old
10
which benefit from medical insurance
will use their electronic card each time
they receive a medical service.
HCLS: This month the ‘health card’
has become operational alongside
existing digitalization mechanisms
such as the use of e-prescriptions.
To what extent will these structures
enable the state to better target health spending and reduce fraud and
wastage?
NB: The economies recovered will
enable us to provide additional funds
and better care to the patients who really need them. If you analyze the way
our spending really influences the general state of health of the population,
this is the area where there are the most
improvements to be made. The real
task at hand to is to improve the nation’s state of health and we resolutely
believe we can achieve this within the
existing system if we deploy our resources more intelligently.
HCLS: Health expenditure in
Romania, at round 4% of GDP remains abnormally low compared
to most other European countries.
Why is this? And what solutions
can you envisage for injecting
more money into the system?
NB: I think that if we don’t have
the means to regulate spending and
don’t envisage healthcare prevention, then even if the government
were to direct a full 10 percent of
GDP towards healthcare, then we
would find that even an amount of
that magnitude would not be enough. The real problem lies elsewhere
and relates to the rationalization of
how we deploy the resources at our
disposal.
I believe that the major problem
is not so much the lack of funds per
se, but rather our use of them. The
way we allocate the healthcare budget should be reevaluated, taking
into consideration the real needs of
THE DOCTOR HEALING ROMANIA’S
HEALTHCARE SYSTEM
Even if the government were
to direct a full 10 percent
of GDP towards healthcare,
then we would find that even
an amount of that magnitude
would not be enough
patients. This constitutes my very
biggest challenge! It is absolutely
pivotal to balance the system, and
to overhaul the way it spends money for the patient. If we can target the funds allocated towards the
areas that display the greatest need,
then we really stand a good chance of balancing the health system, a
sustaining a real equilibrium.
HCLS: What role do you envision
for the private sector in rendering
Romanian healthcare more financially sustainable?
NB: The medical personnel revenue
law will set the pace for introducing more private sector participation within the Romanian medical
system. That way the most urgent
cases will not always be redirected
towards the public hospitals from
the private ones – a phenomenon
that we find burdening our public
healthcare structures today.
HCLS: What steps are you taking to
promote preventative healthcare?
We’ve heard you’ve personally proposed obliging citizens to have check
ups at the doctor at least once every
3 years…
NB: Yes, since last year we have introduced the concept of preventative healthcare within the base health package.
This provides for annual check-ups for
people over 39 years and a check-up
every third year for citizens that are
younger.
We cannot attain good results if we
do not know the health state of the
Romanian population. Also, we have to
mainstream the concept of preventative
healthcare across the entire system because it is easier and less costly to treat
a disease if it is traced at an early phase.
A simple adjustment to the way we conceive of healthcare can reap substantial
rewards both for the patient in terms of
psychology, and for the system’s sustainability, in terms of cost-control.
HCLS: Why has it taken so many
years for successive health ministries to open the reimbursement
list? And to what extent can we now
say that a corner has been turned
and normality can resume (as in regular listing and delisting)?
NB: Yes, the corner has been turned
as you say, and I succeeded because
I studied the system rigorously and
was able to identify the blockages.
I am a doctor by profession and understood that in the absence of a new
list, cost-volume-result contracts, an
emphasis on preventative healthcare,
new methodologies for running the
system and targeted investment, then
Romanian healthcare could not be
made sustainable. The confluence of
all these aspects is what produces the
enabling environment for an enduring
healthcare system that is viable over
the long run and can still accommodate the reimbursement of latest generation innovative treatments. I am
proud to say that we are now firmly
on the right track. I think this represents the biggest success for me as
a minister.
HCLS: How do you see your priorities for the remainder of your
mandate?
NB: New treatments, new molecules,
better infrastructure and better spending control within the system. These
are most important areas that create
the headwinds for everything else.
The rest will follow, as long as we
work even harder!
11
MAN WITH A MISSION
Raed Arafat, Ministry of Internal Affairs
TRAILBLAZER
OF EMERGENCY
HEALTHCARE
Raed Arafat, Secretary of State in the Ministry of Internal Affairs talks
about his mission to professionalize the Romanian emergency healthcare
system. He takes us from the years when he had to contribute his own
money to shore up the system, to today’s challenges: beating short-termism,
coordinating different institutions, and the threat of privatization.
HCLS: You have been personally involved in some of the more momentous events of Romanian healthcare:
specifically your setting up of a mobile
emergency service (the SMURD). Tell
us about that.
Raed Arafat: In the 1980s it was clear
to me that the emergency services were
not working effectively. People were not
adequately trained, vehicles were badly
equipped and there was no overarching
system essential for the system to work
properly. In 1990, we engineered a successful attempt at reform in the regional
city of Târgu Mureș. We created one
team for emergency pre-hospital care, a
mobile intensive care unit with a trained
doctor and nurse capable of responding
to critical emergencies. The system was
fully run by volunteers and initially I was
contributing my own money towards the
effort.
In 1991, I contacted the fire service
and suggested we work together in a
co-operative effort. They agreed to a run
a six-month trial period, which delivered
12
tangible results and represented the beginning of a new relationship between
the fire service and the hospitals. This
was a first for Romania, as previously
there had been no joined up thinking between the two services. In 2007, the then
government invited me to work at the
ministry of health to implement the system top down. Parallel to this approach,
we started developing the air rescue system using World Bank funding.
HCLS: Romanian policymaking in the
health domain is often criticized for
being too short-termist. In emergency
healthcare, however, you have managed to create a more enduring strategy. How have you managed this?
RA: The average lifetime of a minister
of health is around 8 months. This has
had a very bad impact on the Romanian
health system with too much volatility
in policymaking. Emergency medicine
has taken a different path. The fact I am
sitting in the ministry of internal affairs
today represents a radical departure. My
department straddles both ministries
and integrates different actors which
helps ensure continuity.
In emergency care, the ministry
of health could never have done alone what we are achieving today. Not
using the highly professional fire service would require mobilizing expensive alternative private sector resources. The helicopters would have
needed to be outsourced. There would
have instability in the flying component had there been new bidding
rounds for helicopter providers every
few years rather than calling upon the
general inspectorate of aviation from
within the ministry of internal affairs.
The government essentially put under
one umbrella all the resources necessary
for mobile response including emergency medical response. Now operationally we lie under the ministry of internal
affairs, but the ministry of health remains responsible for ambulance services and emergency departments from an
administrative point of view. It ends up
MAN WITH A MISSION
Raed Arafat, Ministry of Internal Affairs
We felt as if we were on the highway in 5th gear
traveling at a fine pace, but the advocates of
privatization would have forced us to depart that
highway and transition to a small, bumpy rural
road of very uncertain direction. This sort
of foolhardiness must be avoided at all cost!
being a very well integrated structure
that can endure over the long term.
HCLS: What you and your team have
managed to create is a beacon example of what can be achieved by making the most out of finite resources.
Is this an isolated instance or can this
sort of integrated model be emulated
and replicated?
RA: It certainly can. There are many
such examples. In 2010, we observed
a lot of acute myocardial infarction
(AMI) patients were not getting thrombolysis or having stents put in which is
the orthodox treatment. The cardiologists came telling us that Romania had
a 13% mortality rate in their therapeutic
area which represented the highest in
Europe. Alarmingly, less than 15 percent of patients were getting stents put in
during the acute phase. This meant they
were likely to develop complications
that would cost the health sector more
money over the long run. The main reason was that the sum of money paid by
the CNAS (Social Health Insurance) to
hospitals couldn’t cover the entire cost.
When the costs are not covered completely, hospitals will be reluctant to spend
money because they will start making
arrears and end up getting blamed for
that.
We came with a new joined-up scheme whereby the CNAS would cover the
cost of hospital drugs and service provided, but not the stent and additional materials which would instead by co-funded out of the state budget. Patients
with acute myocardial infarction would
be entitled to the service, regardless of
there statute of being insured or not, and
the emergency services would also chip
in by providing the transport function of
transferring the patients to the stenting
centers. Due to this unprecedented teamwork involving the ministries of health and interior, the cardiologists and the
emergency services, we today see some
60 percent of patients receiving stents
and mortality has plummeted down to
only 8.2 percent.
HCLS: In 2012 there was an attempt
at privatizing certain parts of the
Romanian health system? You publicly opposed these proposed reforms.
What was the rationale behind this
activism?
RA: What made me react was the insistence by those writing the bill, on liberalizing the emergency response sector.
I considered this proposition not only
as a doctor, but also as someone with
deep convictions formed over a substantial period of time that this sector
must not be privatized.
We live in a country where the average income is low, where access to
care still needs to be improved, but we
have managed to create a public emergency health care system that is working well and importantly can easily be
mobilized in case of disasters. Could
the politicians guarantee that they
would bring something better through
privatization? No. Could they guarantee that the system would maintain its
level of performance? No. All they had
was a vague hypothesis that the market would supposedly regulate itself.
We felt as if we were on the highway
in 5th gear traveling at a fine pace, but
the changes they suggested would
have forced us to depart that highway
and transition to a small, bumpy rural
road of very uncertain direction. This
sort of foolhardiness must be avoided at
all cost. The Health sector in Romania
needs a radical reform, but this has to be
implemented in a very wise and careful
manner always focusing on the interest
of the patients.
13
SEARCH FOR A ROMANIAN MODEL
Private healthcare
ENCOURAGING
A FLEDGLING
PRIVATE SECTOR
TO SPREAD ITS
WINGS
Preface: From a low base, the private healthcare
sector in Romania is growing, and the government
has been trying to encourage it. Its advocates
argue that private health insurance relieves financial
pressure on the healthcare system, but in recent
years it has been hampered by a 2012 draft law
which included hospital privatization. The Ministry of
Health now plans to let doctors use public hospitals’
infrastructure, for a fee.
Written after interviews with: Roberto Musneci,
Managing Partner, SMA, Barbara Cygler, GSK, Dr Wargha
Enayati, Founder and Chairman, Regina Maria, Nicolae
Bănicioiu, Minister of Health, Gheorghe Muşat,
Managing Partner, Muşat & Asociaţii, Raed Arafat,
Secretary of State at Ministry of Interior.
R
omania’s private healthcare sector remains at an incipient phase, but has been rapidly expanding. An increasing number of private clinics have been opened
and are well received by those in the middle and upper income
segments. Hospital chain MedLife, for example, has unveiled plans to open 5 new facilities in the more affluent parts of
Bucharest in 2015 alone.
Private health insurance, meanwhile, has failed to make
much headway. “The penetration of private health insurance
at around 9 percent is clearly a big missed opportunity when
Romania is in such dire need of capital investment. Clearly,
those who can afford it still tend to look abroad for their treatment,” remarks SMA’s Roberto Musneci.
14
The reason for such poor penetration seems to be elemental
economics. “A typical Western European family’s private healthcare insurance will be around 2,000-3,000 euros per annum
for a family of four, while in Romania you would only have a
yearly allocation of maybe 400 euros,” explains Musneci. “The
benefits for the state budget of allowing treatments via private
insurers are obvious and immediate, but the problem is going
to be about how to attract those sorts of entities into the market
when basic purchasing power remains so very low,” he adds.
Lack of workable market data also acts as a significant brake
to any prospective market entrants according to GSK’s Barbara
Cygler. “There’s an urgent need to fix the issue of data compilation, extrapolation and transmission. The private insurance
industry could and should be playing a key role in supporting
the financing of Romanian healthcare, but without sound data,
the insurers can’t properly evaluate risk and calculate premiums so the entire structure remains stillborn,” she claims.
Others, however, believe that Romania should be pursuing
alternative models anyway. “Why try and copy and paste a
template from Western Europe that is not only alien, but increasingly bankrupt?’ wonders Dr Wargha Enayati, Founder
and Chairman of Regina Maria. Rather than a process whereby
insurance is paid to an intermediary, he instead advocates his
own, highly successful, model of direct subscriptions to integrated health maintenance organizations operating their own
polyclinics and hospitals. “Unlike with a middleman, there
is an incentive to maintain running costs at a sustainable level and keep patient subscribers healthy through preventative
healthcare because the provider is simultaneously running the
clinics,” he reasons.
This also represents very much a “home grown solution
born out of the conditions of the local market,” he stresses.
SEARCH FOR A ROMANIAN MODEL
Private healthcare
“It came into being 20 years ago when I started subscription
packages for expatriates working in the embassies and then
broadened the client base to include the new foreign firms entering the market. When they started establishing subsidiaries
all over the country we were compelled to go national and ended up including individual private subscribers as well,” he
recalls. “Today we are functioning right at the cutting edge of
emergent global trends in private healthcare and Romania is
actually one of those laboratories where the subscription model is being experimented to great effect,” declares Enayati.
Meanwhile the state has been trying to entice more private
sector involvement in healthcare so as to ease the burden on
an overstretched public sector. The Ministry of Health has announced plans to introduce a ‘medical personnel revenue law’
allowing doctors to make use of public hospitals’ infrastructure, by paying fees. “The law represents a milestone because it
creates a new field of performing private medical procedures
using the state owned infrastructure, out of hours of the normal
work schedule. This means additional revenues can be redirected towards both the hospital, for use of its medical infrastructure, and to the medic and his assistants for performing the
procedure,” explains Minister Bănicioiu.
Nevertheless many believe recent administrations are guilty
of excessive timidity when it comes to opening the doors to
private healthcare ever since an aborted privatization in 2012
ended in widespread public protests which ultimately brought
down the then government. “Back then the authorities were
pushing for a radical reorganization of the public health insurance houses partly along private sector lines including the
conversion of hospitals into foundations. By packaging the
entire reform into a single bill instead of introducing each element in piecemeal fashion, substantial opposition was able to
mobilize, especially after certain reputable specialists identified major deficiencies in the draft law,” explains Gheorghe
Muşat, managing partner of Muşat & Asociaţii.
One of those highly respected specialists instrumental in his
opposition was Raed Arafat who today vigorously defends his
past actions. “Emergency healthcare should not and cannot be
treated like a vegetables and fruit market. The danger was that
those advocating privatization were willing to meddle with
fine mechanism that had taken years to construct and, once
tampered with, would likely never be able to be rebuilt,” he
reasons. “The health industry requires both public and private
elements, but it needs them in a finely calibrated way. The state
must retain a commanding role otherwise the most disadvantaged strata of the population risk finding themselves locked out
of access to basic necessities,” he clarifies.
15
A FERTILE SECTOR
Fertility treatment
HEALTHCARE AS INVESTING
IN A NATION: FERTILITY
AS A BEACON PROJECT
Preface: Fertility is the therapeutic area which may
yet alter the Romanian view of healthcare as a cost
rather than an investment. It also has the potential to
be sustainable because each new birth is a potential
addition to the labour force in the future.
W
ith healthcare expenditure in Romania all to often
considered by state actors as a cost rather that an
investment in future generations and long term
money saver, the therapeutic area of women’s health could go
some way to shifting mindsets and reversing the paradigm. “The
authorities are finally coming round to the idea that properly
treating infertility can deliver cascade benefits to patient and
society alike,” exclaims Ferring general manager Doru Torge.
“In terms of patient satisfaction, in this particular instance, treatment to a single individual results in more than
one happy customer: that is both the parent and any children subsequently born. On top of that, there are also a significant economic rewards to be reaped. Studies demonstrate,
for example, that for natural births the breakeven point in terms
of contribution for the society, is at 37 years, for assisted reproduction techniques it rises to 40 years old and, for the age range of 40 onwards, the rest represents value additions to society
both in quantitative and qualitative terms,” he explains.
Besides the ethical aspect, there is an economic dividend
to harvest that ensures a high return on investment because with every new birth you have a new potential addition to
the labor force. The authorities have therefore, albeit belatedly, started to address the regulatory framework in a more
enlightened way and one that broadly aligns with European
legislation with a new nationwide fertility program soon
to commence.
For Torge, the therapeutic area of fertility can become “a
showpiece example of how healthcare provision can be rendered sustainable.” “The fundamental aspect looking forwards,
however, will be “to convert this new awareness into tangible
results and to ensure the that the program implementation is
effective and coherent,” he warns.
DORU
TORGE
General manager,
Ferring
16
THE MARKET FOR ADVICE AND ADVISERS
Consultancies and law firms in Romania
BOOM TIME FOR
CONSULTANCIES
Preface: The Changeable Regulatory environment in
Romania has led to a boom in consultancies and legal
firms offering advice on the pharma and healthcare
sector. But more work has not always meant more profit
in these sectors.
T
he fluctuating regulatory framework is generating
extra business for consultancies and legal counsels. “An unpredictable and erratic clawback mechanism is forcing pharmaceutical companies to reevaluate
their operational processes to drive down running costs and
maximize profitability. There is therefore growing demand
for business alchemists who can assist them in rationalizing
their affairs,” explains George Cretu, founder of Enterprise
Concept.
“In many cases, basic operational costs need to be lowered [with] innovative management concepts backed up by
software platforms to correct these processes and diminish
risk exposure.” Cretu gives the examples: “overcoming information asymmetries and accelerating the pace of decision making.”
There is more work for law firms as well. “Integrated law
firms have been reacting to an uptick in demand by bolstering their healthcare industry practices.” observes Ciprian
Dragomir, partner at Tuca, Zbarcea & Asociatii. He says he
has also seen “a proliferation of boutique legal specialists
dedicated specifically to the pharma sector, as the industry
scrambles to comply with adjustments to the legislation and
demonstrates an increased willingness to contest decisions
with litigation.”
But a rising workload does not necessarily mean higher
revenues. “Industry-wide belt tightening has actually resulted in a reluctance to pay stratospheric legal fees. With
so many entities crowding out the market, there has been
a tendency [towards a] race to the bottom on pricing,”
he notes.
17
Romania
WHERE CREATIVITY BRINGS PROFITABILITY
Once touted by the IMS as one of the “fast followers” among
the world’s “pharmerging” nations and feted by the international
investor community in the wake of EU accession, Romania’s
pharmaceutical industry appears resurgent once more after a number
of years on the back burner.
18
COVER STORY
Where creativity brings profitability
I
n 2014, Romania’s market size increased
by a full 6.8 percent to EUR 2.76 billion
[USD 3.12 billion] with Romanians
purchasing OTC drugs to the tune of
some EUR 755 million [USD 853 million] in
the final quarter alone, reflecting an 11.8
percent year-on-year rise, according to
market research conducted by Cegedim.
Meanwhile the country’s newly appointed minister of
health has been both audacious and energetic in radically
reshuffling the rules of the game to place public healthcare provision “firmly on a pathway to sustainability.”
“A corner has been turned and we are well on the way
to establishing the enabling environment for an enduring healthcare system that is viable over the long run and
can still accommodate the reimbursement of the latest
generation of innovative treatments,” explains Minister
Nicolae Bănicioiu.
Such optimism chimes with a national economy enjoying a sharp rebound from the instabilities of the global
financial crisis. Indeed, signs of economic health abound.
Romania is currently registering an admirable 2.7 percent
GDP growth rate, placing it as the sixth best performing
economy of the European Union, and saw its FDI ratio leap
45 percent this year. Meanwhile the country’s exceptional
record on fiscal consolidation continues to generate acclaim. “The current account deficit has narrowed to a mere
0.5 percent representing the lowest level recorded in a decade and making Romania a stellar performer and showcase
to all,” exclaims IMF chief economist Ana Babici.
What’s more, the overwhelmingly positive economic trajectory shows little sign of abating, with the latest
European Commission forecasts predicting four percent
year-on-year GDP increases by 2018. “Romania heralds
a thriving economy, geographical proximity to Western
Europe and a labor cost of only 30 to 40 percent of
Berlin’s. When you take into account these underlying
NICOLAE
BĂNICIOIU
RĂZVAN
VULCĂNESCU
CĂLIN
GĂLĂŞEANU
Minister of health
Secretary of state,
Ministry of Health
BMS country
manager
fundamentals, you’re staring at enticing investment and
production opportunities as well as an attractive trading
partner with disposable income on the up and the average income increasing by around six percent annually,”
enthuses Sebastian Metz of AHK, the German Chamber
of Commerce.
The core attractiveness of the Romanian pharmaceuticals market derives from its potential as growth patterns
in mature markets continue to flatten and Big Pharma embarks on a quest for alternative revenue sources. “Romania
is highly interesting from a pharmaceuticals perspective
because you have a demographic profile that situates the
country as the seventh biggest population after the ‘big
five’ and Poland with some 20-odd million inhabitants,”
observes BMS country manager, Călin Gălăşeanu. “Other
compelling characteristics constitute the prevalence of
certain infectious diseases such as TB where the affliction rate is abnormally high and HIV/AIDS where there
is a very specific cohort of patients.”
“If you calculate the opportunity for market increases
in Western Europe, there is frankly not so much scope for
selling much more. The plateau has already been reached.
Yet Romanian pharma, by contrast, offers much more
mileage. Additionally, if you take into consideration the
fact that per capita consumption here lags at roughly half
of neighboring Hungary, then this is clearly an exciting
prospect where the ‘boom period’ is still waiting to happen,” concurs Bogdan Savu, country manager of Gerot
Lannach.
19
COVER STORY
USHERING IN THE BRAVE NEW WORLD OF
ROMANIAN HEALTHCARE
No one can accuse the incumbent government of being lethargic when it comes to healthcare reform. After an unprecedented seven years of zero new molecules being admitted to the
state reimbursement list, the pharma industry has suddenly
been subjected to a whirlwind of radical refashioning and legislatory upheaval. “The industry has changed more in the past
six months than it has in the entire previous five years,” says
Nolan Townsend, country manager of Pfizer Romania. “Such
a pace of overhaul can, though, yield some nice results.”
Fabrizio Giombini, managing director of MSD Romania,
mirrors that sentiment. “Introducing originators to the local market has been a real challenge for innovative pharma
20
FABRIZIO
GIOMBINI
DR MARIUS
SAVU
NOLAN
TOWNSEND
MSD managing
director
President of
NAMMD
Country manager,
Pfizer
companies for many years. There were several instances
where access to innovation seemed imminent, only for desired reforms to fail to materialize. Eventually, last year, we
finally made some tangible progress towards a new reimbursement system, though there remains considerable ground
to cover,” he warns.
“I believe that we’ve achieved a great many milestones
within a very tight timeframe. We’re talking about the reopening of 26 hospitals, 3,500 new jobs for health practitioners
and a new list of subsided medicines, not to mention the introduction of a national health card and new national programs
for urgent unmet needs,” declares Minister Bănicioiu.
“Not only did we introduce 40 new molecules last year
– a feat simply unimaginable a few years ago – but also we
have implemented an entire supporting architecture to enable
similar updates to be conducted on a regular basis in the future: namely a delisting mechanism, cost-volume agreements
and health technology assessment (HTA) capabilities,” emphasizes secretary of state at the Ministry of Health, Răzvan
Vulcănescu.
Marius Savu, director of the National Agency for
Medicines and Medical Devices (NAMMD), similarly views
the recent changes to public health policy as constituting a
decisive turning point in the history of Romanian healthcare.
“We have been positioning ourselves at the cutting edge of
identifying new pathways in public health that can ensure
stable and prolonged provision of healthcare to those very
citizens who need it most. Radical new concepts that we are
adopting such as HTA and managed access agreements pave
COVER STORY
the way for possibly even biannual introduction of stateof-the-art medicines. Our [hope is] that this new regulatory
landscape will [become] the definitive model for the years to
come, and that future political groupings and governments
will automatically embrace it.”
Not everyone is so unequivocally optimistic, however,
about Romania’s ability to propel itself forward in terms
of healthcare outcomes. “The problem is that, in Romania,
healthcare is all to often considered from a purely economic point of view: how much is spent on medicines. But the
indirect social consequences should be factored in as well.
If life expectancy remains one of the lowest in Europe or if
the number of days spent on sick leave by workers remains
abnormally high then this is going to harm the economy as
a whole and translate into reduced productivity and a lower
tax intake. Under such circumstances the end balance is a
negative one,” argues Gabor Sztaniszlav, general manager of
Amgen Romania. “We believe that, taking into account baseline GDP and underlying growth potential, Romanian society
deserves to enjoy far better healthcare provision. And for that
to happen there has to be more public money injected into the
system,” he stresses.
Indeed, according to the European Health Consumer Index,
which objectively evaluates the healthcare systems of the
EU28 alongside a further eight non-EU European members,
Romania now ranks 35th out of the 36 counties analyzed, with
only Bosnia Herzegovina faring worse. “If you want a healthy
economy you certainly need to invest money in healthcare
LOW DOWN ON AN AVALANCHE OF REFORMS
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COMPLEMENTARY
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COST-VOLUME
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REFERENCE
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PHARMACEUTICAL
MARKETS
CLAW-BACK
TAX ON SALES
OF PRESCRIPTION
DRUGS
ACCORDING
TO MARKET
CONSUMPTION
21
COVER STORY
BARBARA
CYGLER
GABOR
SZTANISZLAV
General manager,
GSK
Amgen general
manager
SENATOR
FLORIAN
BODOG
Barbara Cygler - General Manager,
Romania, GSK
Secretary of
the Health
Commission
because people constitute the main asset of a country,” says
GSK’s general manager for Romania, Barbara Cygler. “The
entire local industry has been built up in barely 20 years with
the rapid emergence of a young medical class with high expectations, but we’re still waiting for that greater cultural paradigm shift that assigns healthcare its true worth as an investment in the nation,” reasons Roberto Musneci, senior partner
“
“
If you want a healthy
economy you certainly need
to invest money in healthcare
because people constitute the
main asset of a country
at Serban and Musneci Associates (SMA).
“This is really problematic,” says Mark Dekker, Astellas’
country manager for Romania, “because unfortunately, there’s
really no other substitute for introducing new liquidity into
the system; none of the new mechanisms being embraced by
the state will be able to overcome such a basic underfunding
shortfall irrespective of how well [they are] applied.”
PRACTICAL STRATEGIES FOR GENERATING PROFITS IN A HOSTILE REGULATORY CLIMATE
DOINA IONESCU
MARK DEKKER
General Manager,
Merck
Country Manager,
Astellas
FOR ASTELLAS IT’S ABOUT
SMART PRODUCT LIFECYCLE
MANAGEMENT:
We’re talking about a very exhilarated
product lifecycle because of the topsy
turvy market conditions that are quite
distinct from anywhere else in the CEE.
As managers, we have to make products
perform that on a normalized market you
might even be thinking about phasing
out. This entails adapting to very different
22
rules of the game and having the creativity to seek out unconventional opportunities and product extensions.” — Mark
Dekker, Country Manager
FOR MERCK SERONO IT’S ABOUT
MAINTAINING A VERY LEAN
OPERATING STRUCTURE THAT
MAXIMIZES MARGINS:
“We focus on the necessary positions
to achieve the revenue stream and
guarantee the service to the community that we have committed to. We
emphasize core competencies. Areas
that we do not regard as core are simply outsourced to specialist providers.
Our dealings with those providers are
also highly rationalized and logistics
represents a case in point. Merck was
actually the first pharma company on
the local market to employ the British
model and only pay a fee for a ‘pick,
pack and deliver’ service. In other
words, we don’t use distributors and
wholesalers if we can avoid it and if
there is no clear value addition to
the patient.” — Doina Ionescu,
General Manager.
COVER STORY
UNTANGLING THE GORDIAN
KNOT OF CHRONIC
UNDERSPENDING
Such assertions touch upon one of
the seemingly intractable issues afflicting Romanian healthcare: chronic underfinancing. “If you scrutinize the macro indicators, Romania
remains well behind the rest of the
EU and some non-EU countries too
for healthcare expenditure. Per capita consumption currently stands at a
meager EUR 85 [USD 97] compared
to a West European average of some
EUR 700 [USD 805], while the state
spends only four percent of GDP on
health, compared to 7.5 and 18 percent in France and the US respectively. Remember, as well, that we’re
talking about a percentage from a
much lower GDP overall, so when
that translates to absolute values it’s
a tremendously low figure,” points
out BMS Romania’s country manager
Călin Gălăşeanu. Indeed, “an annual
spend hovering around the four percent mark places the country more on
a par with Madagascar and Burundi,
than any European counterpart,”
notes Amgen Romania’s Sztaniszlav.
The state, however, remains impervious to such appeals. “I think that
if we don’t have the means to regulate spending, to control any wastage
of money, and if we don’t envisage
healthcare prevention, then even
were the government to hypothetically direct a full ten percent of GDP towards healthcare, then we would find
that even that would not be enough.
The real problem lies elsewhere and
relates to the rationalization of how
we deploy the resources at our disposal,” counters Minister Bănicioiu.
“We certainly want government
health spending to grow, but have to
consider the impact at the macro level
so that an overall budget equilibrium
can be maintained. Besides, successive governments have noticed that,
regardless of how much money has
been allocated directly to healthcare,
we have not been seeing a return on
the investment. While the expenses
increased year-on-year, results did
not follow accordingly which indicates a financial wastage inherent to
the system that first needs resolving,”
says Senator Florian Bodog, secretary of the Health Commission in the
upper house.
Meanwhile the verdict of the IMF
would appear to be strikingly similar. “An important prerequisite to
be able to increase the public spend
would be to put some order in how
the system functions, because we are
confident there is ample room within
the existing envelope to make significant savings and efficiency gains
which could then be directed towards
financing new drugs. If you have a
car losing gas, do you put more gas
into it or instead first try and fix the
leak?” muses Ana Babici.
“This is precisely why we set about
rolling out the national health smartcard,” asserts Vasile Ciurchea, president of the National Health Insurance
Available
and affordable,
as your product
should be
CEGEDIM CUSTOMER
INFORMATION LTD.
Aleea Modrogan 20 et.3
Bucuresti 011826, Romania
petru.craciun@cegedim.com
www.cegedim.com
23
COVER STORY
NAVIGATING A COMPLEX
OPERATIONAL ENVIRONMENT
VASILE
CIURCHEA
PETRU
CRĂCIUN
DAN
ZAHARESCU
President of
CNAS
Cegedim general
manager
Executive director
ARPIM
24
Ferring general
manager
apparent and patients see the ends
benefits.”
Though the utter gulf between
Romania’s present level of healthcare
provision and EU averages might initially appear overwhelming, many remain optimistic that catching up can
swift. “Being a latecomer can actually be an advantage if you learn from
the experiences of others and avoid
the missteps,” reminds Ferring’s
general manager for Romania Doru
Torge. “There can be benefits from a
leap-frog effect.”
“
Developments with the clawback
mechanism and mandatory
pharmaceutical pricing have been
causing a real headache for our
members
“
House (CNAS). “This year the health
card has become operational alongside existing digitalization mechanisms such as e-prescriptions with
the direct purpose of better targeting
health spending. It guarantees there
is no drainage, loss or misallocation
and validates the provision of each
specific medical service by guaranteeing that a patient was presented to
the provider and received the correct
service. Writing fictional prescriptions and selling the drugs elsewhere
will now become much harder,”
he says.
“What’s more, the fact every citizen will have their own electronic dossier backed up on the health
card will enable us to conduct data
mining and extrapolate information for the nation as a whole which
can then be used to inform better
healthcare policy making,” attests
Secretary Vulcănescu. “The only
problem here is that there’s no silver
bullet or switch to be flicked… with
all of these structural steps forward,
there’s always a hefty time lag before
the fruits of the endeavor become
DORU TORGE
The historic healthcare underspend
and ongoing strict cost-control orientation of successive administrations
naturally impacts the operational environment of the pharmaceutical sector.
“Healthcare and the pharmaceutical
markets work hand-in-hand synergistically and need to grow congruently in
order for both sectors to flourish,” says
Petru Craciun, general manager of
Cegedim Romania. “In the Romanian
context, however, the adverse effects
of a stagnating healthcare system are
beginning to spill over into the pharmaceutical market and cause complications for the industry.”
These issues manifest themselves in
a variety of ways. First and foremost is
the widely despised “clawback mechanism”, essentially a sales tax on prescription drugs that is adjusted to cover whatever shortfall occurs between
Dan Zaharescu, Executive Director, Association
for Innovative Pharmaceutical Manufacturers
(ARPIM)
COVER STORY
Courtesy of Zentiva.
the government budget for medicines
and actual consumption. Secondly, the
state enforces mandatory price controls
with pharmaceutical price tags referenced to the lowest denominator of a
basket of 12 EU, but not necessarily
Eurozone, markets.
“Developments with the clawback and mandatory pharmaceutical pricing have been causing a real
headache for our members,” explains
Dan Zaharescu, executive director
of the Association for Innovative
Pharmaceutical Manufacturers
(ARPIM). “By far the most difficult
element to swallow has been the ballooning of the clawback mechanism
from 20 to 26.4 percent despite the
market appearing relatively flat. The
lack of transparency and arbitrariness
over how the contribution is calculated
combined with the sheer lack of predictability of how much is going to
be demanded from quarter to quarter
is causing havoc with our members’
balance sheets and damaging their ability to engage in strategic planning,”
he claims.
Many, however, view factors such
as the clawback more as symptomatic of deeper structural issues rather
than inherently problematic in itself.
“Contrary to what you might suppose, the clawback is not unique to
Romania,” explains Jacopo Murzi,
general manager of Janssen Romania.
“Successful attempts to contain costs
via an analogous mechanism have been
deployed in Hungary, Bulgaria and
Poland. The difference in all those instances, however, is that the clawback
was simultaneously used as a way to
fund expensive novel therapies. Here
in Romania, we are completely missing that side of the equation. It’s being
utilized solely as a device for meeting
current budget requirements with no
forward-looking perspective.”
Roberto Musneci, managing partner
of SMA agrees. “I’m a strong advocate
of some mechanism of clawback tax
because it provides the state with a
financial security belt, but it does not
justify the level of underfunding for
new medicines,” he insists.
BACK TO THE FUTURE:
REPRIORITIZING BRAND
BUILDING
Another curious
feature of the
Romanian market
is the relative lack
of generics penetration. “Generics
currently hold
around 44 percent local market
SIMONA
COCOŞ
General manager
Zentiva
25
COVER STORY
ADRIAN GRECU
Mylan general
manager
LAURENŢIU
MIHAI
APMGR executive
director
share and 24 percent of the value.
Unfortunately we have actually
been witnessing a decrease in presence over the last few years which
is highly unusual for a market such
as ours, with so many unmet needs,
when generics could potentially be
providing a cheaper alternative to
innovative drugs,” bemoans Simona
Cocos, general manager of Zentiva.
For many players, the solution
seems to be about weighting portfolios towards OTC, branching into
supplements and brand-building.
Most of all, ‘adaptability’ seems
to be the watchword. “Romanian
generics is at a strategic inflection
point in Romania due to a combination of factors: on the one hand,
there are industry forces such as
price pressure, a tough regulatory
environment, shifting demographics and increasing patient empowerment. On the other hand, the digital revolution affords us a new tool
to create, deliver and communicate
value. We have to prove capable at
adapting to the evolving landscape
around us,” muses Răsvan Baltag,
26
country manager of Medochemie
Romania.
Quite why generics are gaining
so little traction remains a topic
of intense debate. “This is less to
do with consumer preferences and
more about the behavior of the pharmacists who are forced down a path
of favoring the sale of expensive
branded products in a bid to shore
up their cash registers. The sad reality is that many Romanian citizens
cannot familiarize themselves with
generics when large volumes of the
cheapest drugs are being forced out
of the market by a very hostile fiscal
regime dominated by the claw-back
mechanism,” declares Laurentiu
Mihai, executive director of the
association for generics manufacturers (APMGR) pointing to statistics demonstrating that no fewer
than 1,300 of the cheaper generics
have disappeared from the market
since 2011.
Others are convinced that there
are additional sociocultural forces at play. “It may be connected to
our historical legacy under a communist regime when we did not
possess quality labeled products,
but Romanians are undoubtedly a
brand conscious people. After all,
Romanians don’t talk about trainers or photocopies, but ‘Adidas’
and ‘Xerox.’ Brands are fixed in the
national consciousness which, of
course, is great news for brand managers,” expounds Mylan Romania’s
general manager, Adrian Grecu.
G l e n m a r k ’s a r e a h e a d f o r t h e
Balkans, Lavinia Oprea, supports
this reasoning. “Unbranded generics
tend to perform poorly despite their
favorable price differentials, while
in the prescription market, originators are still king of the game…
this is because consumer tastes in
Romania are very orientated towards brands and launching a product very cheaply doesn’t necessarily
fly as a strategy,” she explains.
The end effect produces some
surprising about-turns in company
strategies with certain players jettisoning the conventional approaches
for CEE markets in favor of a return
to brand building. “Previously we
were pursuing the usual strategy of
building up a portfolio, but increasingly found market demand challenging this thinking,” recollects
Vijay Palamadai, country manager
of Dr. Reddy`s Romania. “This may
be of some surprise to the pharmacists and distributors who tend to
think the market is leaning towards
generics and that we are trying to
swim against the tide, but we feel
differently and will invest in a field
force geared towards establishing
brand loyalty amongst physicians
and consumers rather than handing
out discounts,” he adds. “The reality is that this market is only deceptively a generics market. These
facts have been staring us in the
face and up until very recently we
have been choosing to ignore them,”
he concludes.
COVER STORY
MOBILIZING A “COALIŢIA” FOR COMBINED PROGRESS
RAED ARAFAT
Secretary of state Ministry
of Internal Affairs
JACOPO MURZI
Janssen general
manager
JOINED UP THINKING
FOR A BRIGHTER HEALTH
HORIZON
T h e C o a l i t i o n f o r R o m a n i a ’s
Development, commonly known as the
“Coaliția”, was established two years
ago at the suggestion of incumbent
Prime Minister Victor Ponta, AmCham,
the Foreign Investor Council (FIC) and
two local entrepreneurial groups. The
concept was to provide an effective
platform where private industry can
interact directly with the authorities to
optimize policymaking and identify
commonalities between state and business community strategies.
The healthcare taskforce, encompassing representation from a full
spectrum of pharma industry stakeholders is fronted by Janssen Romania
general manager Jacopo Murzi, and
sits once a month, presenting topics
directly to the PM and ministry.
“Previously, a number of pharma-related associations had been very
vocal in trying to influence national policymaking, but would end up
acting so protectively of their own
interest groups that they would cancel each other out and dilute the voice
of the industry as a whole,” explains
Murzi. “If each individual only takes
care of their respective interests, then
the government is presented with
a cacophony of different voices all
claiming to represent the local industry. We identified that there was no
single vehicle for putting forward
the bigger picture that was truly
representative of the industry in
its entirety. The taskforce strives to
rectify that shortfall.”
“By discarding old-style confrontational approaches we are optimistic
we can coalesce around a common
solution that will enable Romanian
healthcare as a whole to finally realize its full potential,” he adds.
Many are supportive of such an
endeavor. “All in all, the industry
needs to form a united front in order
to ensure that our concerns are genuinely considered by policymakers.
Only through unification will we be
able to secure sustainable win-winwin outcomes for state, industry and
patient,” asserts Cegedim Romania’s
Petru Craciun.
Some point out that there needs
to be greater continuity and coherence on the government side too.
“If your partner of dialogue is changing so rapidly, it’s difficult to forge a
truly long-term strategy,” notes BMS
Romania’s Calin Gălăşeanu, alluding to the revolving door of health
ministers where the average length
of term in office is little more than
eight months.
Solutions to this political volatility can be found according to secretary of state at the Ministry of
Internal Affairs, Raed Arafat, whose
own ‘showcase’ Department of
Emergency Situations straddles both
the Ministries of Health and Internal
Affairs. “We led emergency medicine
down a different path that ensures
continuity and stability,” he explains.
“Through cross-party agreement we
defined a vision that will be pursued
in continuous fashion irrespective of
the personalities is in power.”
What’s more, he describes how this
unique configuration drawing on the
combined support of both ministries
“places under one umbrella all the
resources necessary for mobile emergency and medical response” while
simultaneously encouraging the disparate elements of state apparatus to
combine forces to positive effect.
“Government should never be conducted as a handful of separate autonomous entities, with each ministry
treated in a vacuum. Ministries are
the government’s tool to implement
its vision and serve the population,”
he proclaims.
27
COVER STORY
CONTRACT MANUFACTURING PROWESS
If multinationals have been struggling to adapt their
Romanian strategies, one area of the industry that appears
to be flourishing is the local production segment. Much
of this impetus relates directly to EU accession and the
harmonization of manufacturing standards. “Initially, it
was difficult to enact the transition, because the authorities handed us strict deadlines to make ourselves compliant with European Union legislation. You can describe
it as a short, sharp shock, but once we found ourselves
aligned with international norms, the business opportunities were phenomenal. Having GMP certification opened
the door to a whole world of new possibilities hitherto unknown,” recalls Radu Cazacincu, from the management
28
board of the family-owned, Constanta-based local producer
Magistra C&C.
“The switchover inevitably produced a certain shakeout across the industry with a number of the smaller and
less secure players disappearing entirely from the scene.
Those that managed to adapt to the new rules of the game,
however, were soon rewarded with a whole new host
of foreign partnerships and international contracts,”
concurs Attila Santa, founder of the Brasov-based local
manufacturer Sanosan.
Future trends would seem to favor Romania’s rise as a
manufacturing outsourcing leader. “If ten years ago contract
manufacturing agreements were finding their way over to
India and China, these days, as EU regulations tighten, the
logistical limitations of these arrangements have become
COVER STORY
increasingly apparent and the entire business model
requires a rethink,” explains Santa.
“Countries like Romania are actually the primary beneficiaries,” agrees Cazacincu. “The nation’s local producers
offer competitive and more affordable prices compared to
the rest of the EU and yet our quality standards are equivalent to and, in some cases, even superior due to the modernity of our factories. This ties in very well with a willingness to withdraw contract manufacturing networks from
Asia and re-situate them within Europe,” he adds.
“From an economic perspective there is also a strong
case for leveraging countries located on the fringes of
the EU like Romania for product conditioning and customization because of the attractive cost differentials.
The EU comprises 27 states of very different sizes, each
with their own market specificities and these needs require
segmenting. Romania in many respects offers a platform
for last-minute customization of the batches. The smaller
THE INDIAN CONNECTION
LIFTING THE LID ON A
BLOSSOMING SOUTH-SOUTH
DYNAMIC
Perhaps one of the more startling features of the Romanian pharma market is the vigorous participation of
Indian generics outfits with household
names such as Sun Pharma (formerly
Ranbaxy), Dr. Reddy’s and Glenmark
all carving out sizable niches. Indeed
Sun Pharma currently boasts the largest production facility in sales value in
the entire country having bought out
the iconic local manufacturer Terapia
in the mid 2000s and now contributes
some 700 jobs to the national economy.
Nor is the Indian connection limited
merely to grassroots action. In January
this year, a Romanian trade delegation to Gujarat, fronted by none other
than health minister Bănicioiu himself, announced unprecedented partnerships with the Indian pharmaceutical space for collaboration in the R&D
of new drugs. Under the agreement
signed, Romania's state-owned drug
manufacturing company Antibiotice
Lasi will partner with Aurobindo to
develop anti-viral medicines, with
Macleods Pharma for tuberculosis therapies and with Cipla for oncology products. “This will raise the value of bilateral trade in the pharma sector to well
over the existing USD 3 million,” confirms a visibly enthusiastic Manimekalai
Murugesan, Indian Ambassador
to Romania.
In tandem, Romania will cooperate with Indian businesses for license
acquisition for the sale of Indian medicines in Europe in what must rank as
a new development in the history of
south-south pharma relations. “The
national drug agency will tie up with
Indian companies by inspecting their
products and manufacturing processes," disclosed government spokesman
Mario Crețu.
“In my opinion, the way Indian
firms are doing business is absolutely
phenomenal. Today, the perception of
Indian brands on the local Romanian
market has never been better. If, in
the early days, medical representatives might have been cautious about
revealing the Indian roots of our company, nowadays it is regarded a selling point that symbolizes ‘affordable quality’,” recalls Lavinia Oprea,
Glenmark area head for the Balkans.
“This didn’t happen by accident, but
by virtue of the fact that the Indian
community has been displaying great
solidarity in promoting the “made in
India’ concept,” she adds.
That’s not to say that they all deploy
the same strategies, however. “Unlike
some Indian players that typically view
Romania as a launchpad for pan-European product lines, we consider the
Romanian market on its own terms as
one of our portfolio of emerging markets,” explains Dr. Reddy’s Romania
country manager, Vijay Palamadai.
“Our reading is that Romanian business will grow in a dynamic direction
much more akin to the rapid growth
markets of the developing world than
the mature neighboring European
economies,” he adds.
29
COVER STORY
the batches being prepared, the more the overheads become
pronounced and it’s in instances like this when the cheaper,
more flexible, but highly skilled Romanian labor pool really
comes to the fore,” explains Santa.
“We certainly see a niche emerging for small and medium
size local producers such as Magistra C&C,” admits Cazacincu.
“Our size and geographical proximity means that we are flexible enough to respond to the evolving demands of our clients at
pretty short notice. If, for example, a Western European client
operational across 20 countries in the region wants to suddenly
respond to sales fluctuations by redistributing batches from one
EU market to another, then we have the capabilities to facilitate
this without delay.”
Some multinationals are already starting to arrive at the
same conclusions. “We realized that the educational profile
of the workforce, low labor costs and flexible labor code all
combine to make a compelling case for ramping up investment
in local manufacturing and service support centers,” admits
Pfizer Romania’s Nolan Townsend. “We are actually diverting
product lines from elsewhere and placing them in Romania to
make full use of what we see as a real competitive advantage
RADU
CAZACINCU
VIJAY
PALAMADAI
ROBERTO
MUSNECI
Magistra C&C
management
board member
Country manager,
Dr. Reddy's
Managing
partner SMA
not just vis-à-vis Western Europe, but Central Europe as well.
Products we had previously manufactured in Denmark and
Italy are now being produced here in Cluj at our Ferrosan facility,” he reveals.
“Conceptually, Romania should definitely become a manufacturing hub for the EU and epicenter of European export-orientated production,” suggests Dr. Reddy’s Romania’s Vijay
Palamadai. “I’m frankly surprised more players aren’t yet
engaging in it… I suspect too many minds are still stuck in
VOICES FROM THE INSIDE
INSIDER ADVICE ON WHAT TO EXPECT AND HOW TO SUCCEED…
The Romanian market is an incredible experience and great
arena for cutting your teeth as a young GM: challenging
certainly, but not without real opportunity. Resilience,
patience and flexibility along with a taste for the unexpected
will stand you in good stead. – Fabrizio Giombini,
managing director, MSD Romania
This is no longer a speculator’s market. Those days have
long gone. Don’t think you can just arrive, plonk your
product on the market and make millions overnight. To
be successful requires building-up field force structures,
growing a brand sentiment and committing for the long
haul. – Dr. Tudor Chiuariu, Managing Partner, Chiuariu &
Asociaţii and Former Justice Minister
The unpredictability of the Romanian market renders
strategic planning a very imperfect science so you need
to be at ease with that. The hard truth is that the big
strategic breaks over here generally tend to happen almost
by accident. – Doina Ionescu - General manager, Merck
Beware all those figures presented about the growth of
market because they hide some points that can deviate your
business and upend your strategy. Keep your eyes trained
on the realities and then you’ll do well. – Răsvan Baltag,
Serono Romania
Country Manager, Medochemie Romania
30
COVER STORY
a narrow Romania-centric perspective where they’re fixated
on the potential of the domestic market at the expense of the
much larger potential the country possesses as a member state
networked into European pharmaceutical supply, production
and distribution flows,” he ventures.
ON THE BRINK OF A TIPPING POINT…
MLTRO15NP03302-01
One senses that Romanian healthcare is on the cusp of a new
era. From within the ministries and state apparatus, the mood is
bullishly confident. “There’ll be no waiting around to embrace
smart technology, we’re maneuvering ourselves right to the
frontline of game-changing innovations in healthcare,” assures
Savu of the national agency confidently.
For pharma industry actors, well used to false dawns and creatively having to identify new pockets of profitability in a
fluid policy context, attitudes are more tempered. “I would
say Romanian healthcare is enduring growing pains and it’s
really not entirely clear what exactly will emerge from all
this policy renewal, though the sincere hope is for conclusive
progress this time round,” concludes Cegedim Romania’s
Petru Craciun.
What is certain, though, is that changes are afoot that could
well prove long-lasting. “Double digit market growth is here to
stay, patients are becoming conscious of their rights, local manufacturers are assuming new roles in Europe-wide networks,
and the local leaps in innovative treatment such as for hepatitis
C are emblematic of some new dynamics at play. It’s time to be
optimistic,” says SMA’s Roberto Musneci.
31
INSTITUTIONAL INNOVATOR
Vasile Ciurchea, National Health Insurance
House (CNAS)
REWIRING
THE SYSTEM
Preface: The National Health Insurance House ensures
that every Romanian with national insurance can access
medical services. Its President, Vasile Ciurchea, talks about
making the system more transparent, reducing fraud and
waste, establishing a culture of openness to new ideas
in the institution, and how Romania is leading the way in
Europe by offering access to innovative drugs for hepatitis C.
HCLS: Could you please briefly outline the core functions
and mandate of the CNAS today?
Vasile Ciurchea: As the president of CNAS, my main task is
to ensure the unhindered access of medical services to all those
possessing national insurance while simultaneously guaranteeing transparent and effective management of funds across the
system. My preoccupation is to increase the quality of the services in order to augment patient satisfaction and bring about
an improvement in the nation’s health.
One of my main priorities has been implementing the national insurance card system. After more than 7 years of delays,
the health card has finally become a reality. I am totally convinced that the introduction of this card will limit the possibility of fraud and wastage. Another objective that I have set for
myself is to make CNAS’ workings much more transparent.
We have the duty to inform the insured persons about how
their contributions are being spent.
I also believe that frank dialogue and engagement with the
stakeholders across the entire health system is essential to
bringing about a progression so I have been trying to instill an
ethos of openness and inclusivity. Even contradictory discussion and disagreement can wield positive results.
HCLS: The CNAS has been tasked with rolling out a new
‘national health card’. Just how significant is this initiative?
VC: The national card is a strategic project of profound national
32
interest, essentially aimed at stabilizing the health system. It
will shortly become the one and only instrument of healthcare
confirmation. This way we will be sure that the health system
is used for the purpose intended with all services rendered validated by the recipient. This software solution will ensure
transparency and efficiency in the way in which the money
from the national insurance fund is being expended.
Even though I am aware there has been a degree of reluctance in some quarters in accepting the card, I consider this
to be symptomatic of the normal reticence that people feel
towards change. Make no mistake, this card represents radical change and a decisive step forward.
HCLS: Tell us about the latest reforms to the reimbursement list. How will the new listings and cost-volume agreements combine to deliver a better deal to the Romanian
patient?
VC: The NAMMD has issued the decisions for 51 types of
molecules that will be included in the list of free and compensated drugs. This coincides with a delisting of outmoded
drugs currently reimbursed which will create the necessary
space in the budget to include innovative new medicines.
Another important step will be the conclusion of cost-volume and cost-volume-result contracts for molecules that can
benefit from conditional inclusion in the list of compensated
and free medicines for medical conditions lacking any other
therapeutic alternatives. The specially designated commission for this kind of negotiation consists of representatives
from the Ministry of Health, the NAMMD and the CNAS.
INSTITUTIONAL INNOVATOR
Vasile Ciurchea, National Health Insurance
House (CNAS)
The national card is a strategic
project of profound national
interest… Make no mistake, this
card represents radical change
and a decisive step forward!
Right now we are at the final preparatory stage prior to start
of the negotiations. Through these contracts, the CNAS is
seeking increased patient accessibility to treatment. The contracts based on cost-volume-result agreement will be signed
directly with the drug manufacturers and will explicitly stipulate that the CNAS will only end up paying for treatments
that are effective.
Among the molecules included will be the latest innovative therapies for hepatitis C. These breakthrough treatments
were only recently introduced into Western European health systems and Romania is very proud to be one of the first
Eastern European countries to be offering them.
HCLS: Another opportunity to reduce pressure on the
public healthcare budget would be for private insurance
to assume a greater role. What scope do you see for private insurance and its co-existence alongside the CNAS?
VC: Injecting private capital into the system is very necessary. We are actively exploring ways to enable this. My message is loud and clear: private insurance is more than welcome to step in and start sharing in the financial risk.
HCLS: Currently there are around 300 localities in
Romania without a General Practitioner. We understand
that the CNAS has been considering setting up mechanisms to incentivize physicians to work in locations where
health coverage is low. Can you please elaborate on this?
VC: The CNAS takes this very seriously. That’s why, together with the Ministry of Health, we undertook a series of
measures designed to encourage general practitioner to take
on positions in rural areas and cities with under 10 000 inhabitants. In this regard, we managed to get a normative act
passed which defines uniform, measurable and verifiable
criteria to regulate bonuses that are pegged to the contextual conditions in which the general practitioners operate.
This encompasses not just general practices but also ambulatory clinics and rehabilitation centers. The purpose of
the new regulations is to award financial bonuses contingent
upon the conditions in which the activity takes place which
basically translates to special rewards for those working in
rural clinics.
HCLS: It has been reported that the CNAS annually
pays some EUR70 million for Romanians who undergo
treatment in other EU countries, courtesy of a European
Directive which says that if you can’t treat a patient nationally, he can instead be treated in another EU state.
What practical steps can be taken to stem this outflow of
money and ensure more Romanians are treated at home?
VC: Of course we want to encourage Romanians to be treated at home as this country is blessed with some very good
specialists and it’s obviously far better for the country that
those 70 million euros remain within the national economy.
The way to do this is to implement measures that will enhance citizen’s trust in Romanian healthcare. One of the many
steps the CNAS has taken is to encourage and incentivize
clinics to combine diagnostics and treatment as this tends to
be the norm abroad. The idea is to align Romanian healthcare with standard practices to be found elsewhere across
the EU. It’s also a matter of disseminating information so
that patients can make informed choices. All too often,
a Romanian patient is simply not aware of the treatment
opportunities back home. To this effect we have set about
establishing National Points of Contact tasked with making
sure citizens within their zone receive up to date information about available healthcare providers and the corresponding prices. The essential thing is that patients opting
for treatment abroad should always have a sound rationale
for doing so.
33
SAFETY AND INNOVATION THROUGH
BETTER REGULATION
Dr Marius Savu, NAMMD
FATHOMING OUT
NEW PATHWAYS
Dr Marius Savu, Director of the National Agency
for Medicines and Medical Devices, talks about the
agency’s role ensuring that medicines and medical
devices are safe and that patients can be reimbursed
properly, how he distinguishes real innovation from
‘me-too’ innovation, and reforming the healthcare system
so that physicians and patients begin to take into account
the costs of the treatments they prescribe and consume.
HCLS: Could you please outline the functions and scope of
the agency?
Dr Marius Savu: We have 3 core areas of responsibility.
Firstly, we are responsible for the safety of pharmaceutical
products that are getting to the Romanian consumer. Secondly,
there is the medical device domain which is coming to the fore
in terms of needing to be properly regulated. When you scrutinize new devices entering the Europe market they are becoming more and more intrusive in nature and thus the need to
verify their proper usage and safety is increasing. Our third and
final role, that we assumed only in June last year, is to do with
the reimbursement of pharmaceuticals on the Romanian market. We have extended our activities into the area of health technology assessment (HTA) which represents an entirely new
capability that the agency had never previously possessed.
In pharmacovigilance and medical devices we adhere strictly to longstanding routines. We don’t have to reinvent the wheel. In the health technology area, however, we are one of the
pioneering countries. Like some of the other newer EU member states, we are struggling to balance the access of patients to
the sorts of quality pharmaceuticals they need with attentiveness to the cost to the social system to the extent that that system remains sustainable and viable. We are at the cutting edge
of identifying new pathways in public health that can ensure
stable and prolonged provision.
34
DR
MARIUS
SAVU
Director,
NAMMD
HCLS: How have the recent changes to your mandate
affected public perceptions of the agency?
DMS: They have certainly increased the visibility of the national drug agency because the classic activities are quite technical when talking about pharmaco-vigilance. Now that we
are branching into conducting health technology assessment,
people are beginning to associate us with the decision making
process as to which treatments are awarded reimbursement
status. There is no way of getting away from the fact that
difficult trade-offs will have to be made and that it will be
impossible to keep absolutely everyone happy. It is important
that the public fully understands that when the state apparatus
exercises price cuts and starts the delisting process, none of
the money recuperated will move outside of financing pharmaceuticals. Instead, it will all get reinvested and channeled
towards bringing in real innovation.
HCLS: What, to your mind, constitutes ‘real’ innovation?
DMS: Real innovation versus ‘me too’ innovation must be
taken into account. There is often a logical friction between
the industry and the payer, but it is possible to engineer winwin outcomes. We fully understand private industry’s right
to patents and exclusivity for the value added research behind a particular product that has been invented. R&D for
breakthrough medicines does cost a lot and it is entirely right
SAFETY AND INNOVATION THROUGH
BETTER REGULATION
Dr Marius Savu, NAMMD
The idea is not to wait to utilize
smart technologies, but rather
to position ourselves right at the
frontline of these sorts of
game-changing developments
that there should be channels for recuperating those expenses.
When a firm starts to move into line extensions that no longer
constitute real innovation, then you start testing the limits of
what is acceptable because these loopholes deprive patients
from gaining access to real innovation. Because state public
budgets are finite, having the state finance me-too innovations
comes at the direct cost of being able to finance real innovations and this is when the patient is the one that loses out. This
is a scenario that is simply not acceptable.
There are cost-efficiency implications for the clinical trials
sphere as well. A lot of trials are versus placebo whereas in
the future there will be greater need to demonstrate that you
are better than a specific existing treatment. You might, of
course, be better than placebo but it doesn’t necessarily signify that there is a real need for your product in the patient
category. If you are only marginally better then you shouldn’t
claim you are real innovation. These are the sorts of elements
that need weeding out so that we can refocus the money we
have on where it will deliver the biggest impact. We basically
require a rationalization exercise.
HCLS: How can the Romanian healthcare system become simultaneously more effective and more sustainable in
terms of expenditure?
DMS: When you start to do the basic arithmetic, then you
realize the public healthcare system is not sustainable in its
current form. This is partly because there is little linkage between the payer (the state), the prescriber (the physician) and
the end customer (the patient) in terms of economics. Neither
the physician nor patient take any real interest in the cost of
the treatments they are prescribing or consuming: their only
concern is to secure the most medically effective therapeutic solution for a given illness. From an economic standpoint
the incentive structures are simply not there to produce
cost-effective outcomes. Nowadays with increasingly targeted therapies appearing on the market for oncology we can
expect the cost of healthcare to soar even higher.
The impetus is on the state to strike the right balance between bringing innovative and highly effective products into
the market and being able to pay for them. Outside of the box
solutions have to be found. A real radical rethink is needed
about how we go about delivering public healthcare. Though
we are far from alone in grappling with this problem we are
one of those countries, at least within the EU, where these
issues are played out more sharply.
HCLS: So, looking forward, what will be the next steps to
realize this objective?
DMS: There is an advantage to being a latecomer in that we
can take the biggest strides forward in the shortest space of
time. We have resolved upon criteria for introducing and delisting molecules and the legislation now exists for the managed entry agreements. Most of the basic building blocks are
now in place. The next stepping stone will be to set about seeking out additional efficiencies. There should be a step-wise
approach in which we gather the low hanging fruit first before moving on to other smart forms of healthcare provision.
Future sustainability will ultimately hinge upon preventative healthcare, greater patient autonomy and ensuring the
product being prescribed is the optimum one. We should even
start channeling money towards genotyping in order to verify
that prescribed therapies will generate the desired effect on a
specific patient. The idea is not to wait to utilize smart technologies, but rather to position ourselves right at the frontline
of these sorts of game-changing developments.
35
SPECIALITY CARE BIO-PHARMA
Călin Gălăşeanu, Country Manager
of Bristol-Myers Squibb
BROADENING
THE SPECTRUM
TO BIOPHARMA
Preface: Bristol-Myers Squibb targets disease areas with
high unmet medical needs - and finds opportunities in
Romania for treating mental illnesses, HIV/AIDS and
Hepatitis B, and in oncology and hematology. Călin
Gălăşeanu, Romania's Country Manager, talks about the
expansion of Romania's reimbursement list, innovation,
and the country's wider healthcare system.
HCLS: BMS is a specialty care bio-pharma business
that has been present on the Romanian market since
1995 and currently ranks number 13 in terms of market share. Can you please introduce the scope of BMS’s
in-country offering?
Călin Gălăşeanu: Over last 20 years, BMS worldwide
has been transitioning to a pretty unique business formula
which has centered around highly specialized care that specifically targets disease areas with high unmet medical needs.
Romania’s national healthcare profile, with demand outstripping supply in critical therapeutic areas, aligns closely with
this approach so it is entirely natural that we have been and
continue to be highly active in this country. We have established a strong presence in Romania initially for treating mental
illnesses and more recently for our therapies to counter infectious diseases such as HIV/ AIDS and Hepatitis B. Last but not
least, we are developing innovative medical solutions for the
oncology and hematology segments.
At the global level, we have been at the forefront of
breakthrough developments related to the role that the immune system can play in fighting cancer and have been successfully pioneering the concept of immune-oncology. Our
plan for Romania includes introducing these cutting-edge
methodologies and latest generation products for the benefit
of the Romanian patients. At Bristol-Myers Squibb, we feel
36
CĂLIN
GĂLĂŞEANU
Country Manager
of Bristol-Myers
Squibb
strongly that Romanian patients deserve to enjoy the same
level of healthcare as their counterparts across the EU. We
very much see our role as helping to drive up the standard
and scope of health provision in the therapeutic areas where
we are leaders.
HCLS: As a member of the new generation of GMs, what
are your techniques for successfully navigating the regulatory landscape and ensuring profitability on the local
market?
CG: The best way to navigate the regulatory landscape is to
play an active role in engaging with relevant stakeholders
to build a right communications platform. This might sound
trivial, but speaking with a single voice in the industry is
essential if we are going to be able to facilitate access to optimal innovative treatment for Romanian patients. BristolMyers Squibb is a vigorous member of ARPIM, an association for innovative drug companies engaged in Romania,
and I am actually the incumbent president. At Bristol-Myers
Squibb, we consider it vitally important to be active participants in such configurations because this is our best chance
to be heard by the authorities and to impact the decision
making process.
SPECIALITY CARE BIO-PHARMA
Călin Gălăşeanu, Country Manager
of Bristol-Myers Squibb
Romania has had to cut corners
since 1989…the result is a lopsided
and only part-developed market
that lacks in maturity
Obviously, trying to identify the lowest common denominator for 28 innovative pharmaceutical multinationals is
always tricky, but we have managed to unanimously agree
upon three pillars and core values which we consider incomplete or absent from the local market and are relentlessly pursuing: transparency, predictability and financial
sustainability.
HCLS: BMS represents a new breed of bio-pharma company, uniquely combining the reach and resources of a
traditional “big pharma” player with the entrepreneurial dynamism and agility of a biotech outfit. You also
enjoy one of the most productive pipelines in the industry. What opportunities, then, are there in the Romanian
market for a firm like yours?
CG: Our bread and butter activity is innovation so our intention is naturally to channel that productive pipeline towards
the local market. Romania has had to cut corners since 1989
and sometimes they achieved this successfully, sometimes
not. The result is a lopsided and only part-developed market
that lacks in maturity even if many of the main private sector actors have been present for the past 20 years. This may
limit our space for action in the short term, but does nothing
to reduce the reality that we have a major contribution to
make in assisting Romanian healthcare get on to its feet.
The opportunities that are out there are clear for all to see.
Average life expectancy across the EU is 83 to 84 years whereas in Romania it's a full ten years less and this is linked
directly to the comparatively poor quality of the healthcare
and reduced access to innovative therapy. We have, alongside
other pharmaceutical innovators, positioned ourselves to address this shortfall.
The outlook is bright. What happened last year, with a tentative opening up of the reimbursement list, was not by chance and was actually the culmination of a highly coordinated
effort on the part of ARPIM with harmonization at the EU
level and vocal lobbying by the patient groups as well. There
was a bottom up approach where the civil society groupings
started demanding their rights, similar to all patient advocacy groups in the rest of Europe. They’re becoming more empowered and a degree of maturity is materializing.
HCLS: How strategically important is the Romanian market to BMS’ global operations?
CG: If I look at our current geographical footprint, Romania
is without doubt one of the heavyweight players in BMS’
CEE basket of countries. We enjoy a decent growth rate due
to our agility in delivering good results with legacy products
despite not having new items on the reimbursement list.
Behind all the facts and deeds is a professional, dynamic and
enthusiastic team which goes a long way to ensure success.
Speed, agility and versatility are crucial to reach our goals
in this market. You need an energetic and forward-looking
team fit for the purpose of creatively adding value when the
rest of the market is tired and exhausted.
37
We’re talking about an
under-regulated and free
market with open doors and
substantial growth prospects
AN UP AND COMING SECTOR
The medical device market
THE
FLOURISHING
MEDICAL DEVICE
MARKET
Alexandra Petrila, Link Resource
Preface: The Romanian Medical Device market is
worth more than $400 million USD, is growing at over
2% a year, and offers many opportunities for foreign
manufacturers. But experts warn it is severely
under-regulated, leading to occasional extreme results.
The regulatory framework is likely to change soon.
Written after interviews with: Alexandra Petrila,
co-founder, Link Resource, Marius Savu, NAMMD,
Jacopo Murzi, General Manager, Janssen Romania.
R
omania’s medical device market is currently valued
at USD 436.6 million and is expected to maintain
growth at a CAGR of at least 2.9% over the period
2015-18. What’s more, imports account for a full 90 percent of
the market meaning significant opportunities for foreign manufacturers. “It’s an attractive niche to be operating in… we’re
talking about an under-regulated and free market with open
doors and substantial growth prospects,” explains Alexandra
Petrila, co-founder of the health sector consultancy, Link
Resource. “The only flipside of being so free and wild is that
market data is pretty difficult to capture so it can be tricky to
understand how to target your products,” she adds.
This state of under-regulation could be soon set to change
however according to Dr Marius Savu of the NAMMD. “When
you scrutinize new devices entering the Europe market, they
are becoming more and more intrusive in nature and thus the
need to verify their proper usage and safety is increasing. Far
greater oversight is required for echographs and implantable
devices that could be hazardous to public health if not up to
specification or improperly handled. For these reasons we will
38
be seeking to bolster our inspection capabilities and revisit the
regulatory framework,” he reveals.
This news will be welcomed by multinationals operating at
the more technologically advanced end of the medical device
spectrum. “The stumbling block to date for J&J has been that
there hasn’t been any kind of functional health technology assessment methodology in force that would enable a true evaluation of the value of our devices,” explains Jacopo Murzi,
General Manager at Janssen Romania. “Clear legislation on
tenders is also missing and we even witness instances where
patients are bringing their own medical devices into the surgeries because the hospitals cannot afford the most superior
products on the market. Once these final pieces of the jigsaw
are in place, however, we can expect this market segment to
properly take off and there’ll be plenty of business all round,”
he forecasts.
CONSOLIDATION, ACQUISITIONS,
AND CHANGE
Pharmacies in Romania
CHANGES
AFOOT IN
ROMANIA’S
DISTRIBUTION
AND RETAIL
CONFIGURATION
Preface: Romanian Pharmacies are going through a
period of consolidation. Four distributors now control
more than three quarters of the market, and more
acquisitions and mergers are expected. This wave of
change is altering the relationship between buyers
and sellers.
Written after interviews with: Ovidiu Buluc, owner,
Farmexim, Radu Pavel, founder, Ecofarmacia , Iulian
Trandafir, CEO, Farmexpert.
R
omania’s distribution and retail landscape has long
been notorious within Europe for its complexity
and expense. In recent years, however, a process of
normalization has clearly been underway as both stages of
the value chain undergo consolidation. “A decade ago, there
were over 300 distributors and now there are only 12 with
market shares above 1 percent of which the first 4 control
over 75 percent and we can still expect further acquisitions
and closures,” explains Ovidiu Buluc, owner of leading
wholesaler, Farmexim.
Much of the volatility in the distribution segment is directly
down to insolvencies at the pharmacy level. “There are simply
too many pharmacies. Despite recent trends in which the larger chains have been eating up the smaller independent outfits,
Romania still has over 8,000 pharmacies whereas the country
only requires around 5 to 6 thousand,” analyses Radu Pavel,
IULIAN
TRANDAFIR
OVIDIU
BULUC
RADU
PAVEL
CEO, Farmexpert
Owner, Farmexim
Managing Partner,
ECO Farmacia
founder of Transylvanian chain, Ecofarmacia and pioneer
of the “neighbourhood pharmacy” concept of geographical
proximity and quick re-stockage. “A good 2,000 could be said
to be without profitability, making losses and will ultimately be unable to pay the wholesalers for the pharmaceuticals
they’ve taken on credit,” agrees Buluc.
This can make for some novel interactions between the
wholesalers and the retailers. “At Farmexpert, we resolved to
step out of a traditional buyer-seller relationship, becoming
a genuine partner to our clients, by helping them to improve
their solvency by delivering much needed support and expertise in areas such as financial management and planning,” explains CEO Iulian Trandafir. “For wholesalers in the Romanian
pharma market, the key to survival is frankly not in the selling,
but rather in being able to control the risk…the problem is not
in riding the horse, it’s the horse itself,” he concludes.
39
READY TO SPECIALIZE
Vijay Palamadai, Dr Reddy’s
MAKING BRANDS
KING
Vijay Palamadai, Country Manager with Dr Reddy manufacturer of Omez, a product to reduce stomach
acid - talks about why the company is prioritizing
stability, concentrating on gastroenterology, respiratory
psychiatry and oncology, and why he does not buy into
the conventional wisdom that building up a portfolio of
generics is the best strategy.
HCLS: Tell us about the structural changes taking place in
Dr Reddy’s in Romania and the heightened emphasis placed on marketing?
Vijay Palamadai: Four years back, when I joined the local
team, the function of marketing manager didn’t even exist. At
that moment, the local market was in the midst of a transition
and the clawback tax had just been introduced. Meanwhile our
in-country portfolio was getting somewhat stagnant. In the absence of getting much from new launches, the local management wanted to bring in a specialist able to leverage existing
assets to make them grow at a faster pace as well as to shift the
overall business strategy to being more in line with the evolving market realities.
A little creativity can go a long way to creating success in the
Romanian marketplace and the importance of strong marketing
has become more pronounced. A decision was therefore taken
to elevate me to the role of country manager from which I can
push forward a fresh, very brand-orientated strategy.
HCLS: Please explain how the company’s local strategy has
evolved in recent years.
VP: The new approach that we have adopted is to transform
ourselves from being perceived as a generic company to a
branded one. The launchpad for doing this is our star product,
Omez, which represents our lead product constituting a full
60 percent of local revenues. This is therefore the brand that
40
VIJAY
PALAMADAI
Country
Manager,
Dr Reddy’s
we have identified that we feel can drive our thinking forward.
If we can create the right sort of connection with the patient so
that he or she believes this product provides maximum relief
from his or her affliction, then already we have generated a
much more sustainable business than previously.
To date, stability has been the missing element in our
Romanian operations. We could place a decent product on the
market and have high expectations, but by the end of the year
you could already have been subjected to a massive price correction. Suddenly the product you viewed as a significant revenue generator for which you’ve already invested heavily in
building up an appropriate field force has dropped to a tenth
of the level of its original profitability. We have seen so many
examples of this scenario over recent years that we have decided to opt out of that game and instead to go down the branded
approach.
HCLS: What are the hallmarks of this branded approach?
VP: Well we have identified certain therapeutic areas – gastroenterology, respiratory psychiatry and oncology – whereby
we already possess the visibility of a pipeline and have complex generics coming through. We are not looking at zero-value
assets, but in acquiring brands that already have some awareness across the market. Searching for these brands actively, we
inform potential partners that their brands look stagnant and
present solutions on how to overcome that loss of momentum.
READY TO SPECIALIZE
Vijay Palamadai, Dr Reddy’s
Previously we were following
the conventional approach of
thinking of building up a portfolio.
However we increasingly found
the market demand challenging
this thinking
We then demonstrate how we can speedily build a customized infrastructure appropriate to assist such products
perform better.
HCLS: This surely entails a significant shift in mindset…
VP: It certainly does. Previously we were following the conventional approach of thinking of building up a portfolio.
However we increasingly found the market demand challenging this thinking. This may be of some surprise to the pharmacists and distributors. They tend to think the market is leaning towards generics and that we are trying to swim against
the tide. They will tell you that there is no point investing in a
brand when others will launch generics at a discount and take
away our business. We feel very differently. We will invest in
convincing hearts and minds of the benefits of our products.
The reality is that this market might give the appearance of
being a generics market but it isn’t in the proper sense. Generics
penetration isn’t making anything like the sort of progress in
Romania as it should be. These facts have been staring us in the
face and up until very recently we have been choosing to ignore
them. 2015 will, in this way, be a crucial year for the new strategy. It will be the year we dramatically change our behaviors
and habits to reflect the realities of market demand.
When I see that 17 percent of our revenues came from OTC
in April whereas it was under 3 percent at the end of last year,
it adds to my conviction that we are on the right path in spite
of the naysayers. Equally, the amount of commercial threat that
Omez is under from its two nearest competitors in terms of pricing and placement is immense and yet the patients and doctors
continue to believe in the quality of the brand and that signals
to me that we are dealing very much with a brand-orientated
market demand.
HCLS: What steps are you taking to convert this thinking
into hard action?
VP: We are trying to bring in the right kind of people in terms
of mind-set. In January, we created a new line of field managers who have slowly but surely been embracing the concept
of Dr Reddy’s as a brand driven company. We have 10 months
to change mentalities and set the action in motion.
Omez has become an organizational priority for us. It has
transcended being just a marketing team priority. We can use
it as a test case to piggyback on and demonstrate why it is
important to believe in the power of brands. It’s a break-through project which we can harness to inspire the belief in the
brand-orientated approach.
41
MYLAN: EXPERIENCE AND INNOVATION
Adrian Grecu, Mylan
RIDING THE WAVES
OF CHANGE
Adrian Grecu, General Manager of Mylan talks about the change in mindset
required given its acquisition of Abbott, why Romanians are willing to pay for
trusted brands, and the challenges of a changeable Romanian environment.
HCLS: Maybe you can start by telling
us about last month’s acquisition of
Abbott by Mylan.
Adrian Grecu: Historically Abbot
was a patented drugs company where
we were selling originals. At the time
of the Mylan acquisition our entire portfolio became off-patent and in all segments we had generic competition. We
were coming from the patented world,
but moving towards the generic one,
but still with the mind-set of an innovator. For us the primary focus in terms
of customers has always been the doctors. Now we have been acquired by a
company that is coming from the other
end of the spectrum, which will require
a change of mind-set in our approach to
the market.
HCLS: Every company has its own
corporate identity, its own philosophy.
How do you see the shift, with Abbot
having a very well defined approach,
to the Mylan ethos?
AG: Abbot from a public opinion perspective has been perceived as a stable,
conservative company, without necessarily achieving high growth, taking a
42
long-term approach. Mylan is a younger company, although it has now
been around for 54 years. What I have
noticed already is that both companies
have very similar values, with an emphasis on integrity, innovation and a
customer orientation. There will be a
push to be more focused on commercial
expansion, with a slightly more aggressive approach, and perhaps sacrificing
some short-term gains in terms of the
bottom line.
Abbott adopted what I consider a
very traditional American approach aimed at fostering sustainable growth and
in the last 12 years I have become very
familiar with this approach. Mylan being very ambitious as a company, looks
for rapid growth so is likely to embrace
a different approach in which the strategy is much more orientated towards
extending our activity on the market
side. It is very important when looking
at the Romanian rankings to remember
that increased sales does not necessarily
mean increased profits. Many generic
companies offer considerable discounts
which could cut around 10 to 20 percent
of the market size.
HCLS: How do you see your future
product portfolio matching the epidemiological transition of the country and of the patient?
AG: My view is that if we want to
serve seven billion people, then we
have to be present in almost all therapeutic areas. There is also a real
push from the Romanian authorities
to encourage the use of generic products, which is far behind the level
of the USA, and I do not believe it
will ever make such a breakthrough
because something that distinguishes
our population is that we are very
much brand orientated. Brands matter
for the Romanians. It does not always
come down to the price. We are often
willing to pay a premium for a product that we trust.
HCLS: How does one explain that
rationale in terms of consumer
preferences?
AG: It may be connected to our history as a communist country, where
MYLAN: EXPERIENCE AND INNOVATION
Adrian Grecu, Mylan
It is very important when looking at the
Romanian rankings to remember that increased
sales does not necessarily translate into
increased profits
ADRIAN
GRECU
General Manager
of Mylan
we did not have quality products on
the market. After the revolution in
1990 there was a saying that went
“I am never too poor not to buy a
German car” because even if you opted for a second, third or fourth hand
one you would still consider it superior to a new Romanian brand one.
There are plenty of examples of a generic drugs that are considerably cheaper, by as much as 30 percent, and
yet people more often than not opt for
the originator. Nevertheless there is
obviously an affordability threshold
above which, no matter how strong
the brand may be, the consumer will
prove not willing to pay.
What I know for sure is brand matters and the figures bear that out with
generics not making the same level
of penetration as in other markets
across the CEE. At the end of the day,
brands that have been well built so
that the nation trusts them are able to
charge 30% more and they will still
find a ready supply of buyers.
HCLS: You background is on the
financial side. That could be an advantage in a market where there are
a lot of financial distortions. How
do you navigate this complex web of
distortions?
AG: The market would certainly shape
up rather differently if we didn’t have
the claw-back which is tantamount to 25
percent today. Having a financial background is a strength that matters, but
must be kept in proportion to the other
functions such as marketing sales and
scientific knowledge. In this volatile
market it does help though to know how
your actions can translate into bottom-line profits. Some actors are concentrating
more on the OTC market to escape the
claw-back, while others are orientating
themselves more towards exports.
At Mylan, we know that the OTC
segment is a missing piece. It is incontestable that those players that possess
such a portfolio have performed better
overall. Despite the need to factor in the
extent of discounts being awarded, the
OTC market certainly looks on the face
of it to be pretty comfortable.
There is no single magic formula
to navigating the Romanian market.
Seemingly opposing strategies can
both work in different instances. The
crucial factor is to understand your respective strengths in certain segments.
HCLS: What do prospective market entrants need to know about
Romanian pharma?
AG: The flurry of legislative change
we have been witnessing poses real
challenges for a manager. We can’t
forecast for the next 6 months let alone the next 6 years. Last year everyone was very negative and the market
actually ended up being pretty good.
If we had been able to forecast that
beforehand then we may have invested even more. The instability makes
us less efficient than we would
otherwise be.
Romania is an important market
that will grow and people are ambitious so all the key ingredients are in
place except continuity and coherence. All in all, this is certainly not a
market for the fainthearted. There are
sure successes to be had, but incoming
entrepreneurs should be prepared for
the volatility and expect the unexpected. Each day must be taken as it is.
43
ROMANIAN LEGAL PIONEER
Gheorge Muşat, Managing Partner
of Muşat & Asociaţii
NEEDLES IN
A HAYSTACK:
selecting the right
legal partner
in an increasingly
crowded field
Gheorge Muşat, one of the market builders of the
Romanian legal sector, talks about how his law firm
Muşat & Asociaţii works with the Romanian pharma
sector, the consolidation he expects to see in the
coming years in the distribution and pharmaceutical
retail sectors, and the move towards more mergers,
restructurings, and legal work connected with pricing
and reimbursement.
HCLS: As one of the original ‘market builders’ of the commercial law practice in Romania, what is your assessment
of the state of legal provision to the Pharma sector: how
well equipped are Romanian law firms in catering to the
needs of big pharma today?
Gheorge Muşat: I was one of the original market builders.
The legal sector was liberalized only a full 6 years after the
overthrow of Ceausescu. We had much more determination
that any incoming foreign lawyers because we were waiting
so long to see the communist regime closed down. In those
early days, Investors were in need of legal advice because new
laws were being passed every day. Also concepts like ‘privatization’, ‘angel investors’, and ‘joint ventures’ were all thoroughly alien concepts.
Today law in Romanian has become normalized and we
practice pretty much like any legal firm in Europe. Firms like
ours have all the capabilities that a pharmaceutical sector client
44
GHEORGE
MUŞAT
Managing
Partner of Muşat
& Asociaţii
will require so the standard of legal provision is more than adequate. The entities that stand out as being the best to cater to the
needs of the Romanian pharmaceuticals industry are those that
know the inner workings of the system and have that insider
perspective. In that sense any reputable chambers providing
counsel to local pharma players has to possess that ‘boutique
dimension’ even if they are a fully integrated service firm.
HCLS: To what extent is legal provision to the pharmaceuticals sector becoming more competitive with the emergence of specialist boutique consultancies at the local level
alongside increased participation of fully integrated multinational law firms?
GM: In so far as the specialist boutiques are concerned, we
do not see them as true competitors. While we offer the full
range of legal services handling everything from regulatory
to M&A, antitrust to IP, tax to insolvency, they tend to be
limited to single issues. Furthermore, even if a pharma company might decide to involve a specialist boutique for a specific legal matter or for a specific project, they might also
request our assistance in order to ensure the overall coordination and supervision of the respective project and to provide
the necessary legal services.
The real competition for work right now is to some extent related to in-house legal divisions. There seems to be
a growing tendency for pharma companies to set up their
own internal counsel and, often misguidedly, consider that
ROMANIAN LEGAL PIONEER
Gheorge Muşat, Managing Partner
of Muşat & Asociaţii
adequate for their needs. They call on us for the most sensitive cases and think their internal legal department can handle
the less sensitive tasks. Often they cannot and the supposed
cost savings end up being elusive. It is all well and good to
have internal lawyers for internal affairs such as drawing up
of employment contracts and laying off staff, but when you
come to matters such as external litigation then you really
need the assistance of experts. Some companies are tempted
to overlook this fact and end up learning the hard way.
HCLS: Do you agree with PwC’s assessment that in 2015
will likely be a year of high M&A activity for Romanian
Pharmaceuticals?
GM: Yes, we agree. The pharmaceutical market in Romania
is going through a difficult period, not only at the level of
the producers/manufacturers (e.g., due to the high level of
the clawback tax, the reduction of the medicines’ prices announced by the authorities for 2015), but also at the level
of wholesale distributors (some of them facing significant
financial difficulties due to the failure to collect money from
their debtors, the pharmacies) and at the level of the pharmacies (many of them facing the risk of bankruptcy). This might
lead to the concentration of the market, and certain small and
medium-sized transactions are anticipated.
While we do not necessarily expect a high degree of M&A
activity in relation to the producers, we expect certain consolidation in the distribution / retail (pharmacies) sectors.
We are already witnessing the initiation of insolvency
proceedings in connection to major distributors on the market, such as ADM Farm. The Polisano group, which includes
both the wholesale distributor Polisano and other companies
acting in the healthcare & medical services fields, have also
announced that they intend to divest certain commercial
activities and business lines.
HCLS: Where do you identify the main areas of workload
looking forward?
GM: In the coming years, certain significant changes might be implemented in the pharma and healthcare fields in
Romania, and our clients will require specialized advisory
and legal representation services. The matters on which we
anticipate working for our clients in the following years include: (i) assistance in connection with transactions, mergers
and acquisitions, divestments, restructurings and reorganizations; (ii) guidance in connection with the changes that might
be implemented by the Romanian authorities (e.g., in relation to the medicines’ pricing, the clawback tax, the medical
services, the public health insurance system, other regulatory
matters); (iii) assistance in connection with pricing & reimbursement matters – including the update of the list of reimbursed medicines. On top of that, we will expect the usual
workload in the areas of competition matters of IP protection,
litigation, taxation and compliance all of which concern our
pharmaceutical clients.
45
EFFICIENCY, SPEED AND OPPORTUNITY
Clinical trials in Romania
VIBRANT CLINICAL
TRIALS MARKET
Preface: Romania is starting to hold its own as a destination country
for clinical trials. Its costs are low by European standards, sites can be set up
quickly and patients enrolled easily. However fewer clinical trials per head
are conducted in Romania than neighbouring countries; there is still plenty
of slack left in the Romanian clinical trials market.
Written after interviews with: Călin Gălăşeanu, President, BMS,
Doina Dobjanschi, Senior Director of Clinical Operations, Contract Research
Organization, George Badita, Vice president for Clinical Development,
INC Research, Bujor-Eugen Almasan, President, Association of the
Companies Coordinating Clinical Trials in Romania (ACCSCR), George
Tanaseanu, General Manager, PSI.
A
nother
feature
of
the
Romanian healthcare and life
sciences is the high volume
of activity in the clinical trials arena.
“At the level of ARPIM, our member
companies contributed a combined investment of some 400 million euros
last year,” notes BMS’ Călin Gălăşeanu
who is also the sitting president of the
association. “In a country with late
access you can easily spot immediate benefits from engaging in clinical
research. Firstly you can have a good
chunk of the population accessing very
innovative drugs. Secondly, you are
raising the bar for local doctors who
will gain exposure to cutting edge
treatments and methodologies. Thirdly
it also produces a cost-saving effect on
the public purse as clinical trials operate outside the reimbursement system,”
he reasons.
46
Many would say that Romania is now
really beginning to hold its own as
a clinical trials destination country.
“Romania enjoys the 2nd largest population in Central and Eastern Europe
(CEE) and large market size equates
to lots of patients so that is definitely a plus factor. The healthcare system is also decent and operationally
functioning so we can identify good
research sites and investigators for our
activities,” explains Doina Dobjanschi,
senior director of clinical operations
at the Contract Research Organization
(CRO). “The costs of monitoring, enrolling and conducting studies are also
significantly smaller than in other countries... we can enroll eligible patients
faster and in higher numbers than for
any equivalent study in North America
or Western European countries and the
same goes for the speed of time taken to
execute contracts and set up sites,” adds
INC Research’s vice president for clinical development, George Badita.
Romania’s competitive advantage
is not completely uniform, however.
“The bulk of the trials being performed
constitute phases 2, 3 and 4. The volume
of phase 1 remains fairly modest because
DOINA
DOBJANSCHI
BUJOR-EUGEN
ALMASAN
GEORGE
TANASEANU
GEORGE
BADITA
Senior Director of
Clinical Operations,
Contract Research
Organization
President, Association
of the Companies
Coordinating Clinical
Trials in Romania
(ACCSCR)
General Manager, PSI
Vice president for
Clinical Development,
INC Research
EFFICIENCY, SPEED AND OPPORTUNITY
Clinical trials in Romania
FOCUS
ON QUALITY
C-GMP FACILITY
• TABLETS
• COATED TABLETS
There’s a huge amount of slack in the market
still to be exploited. The cake is big enough for
everyone
• SUPPOSITORIES
• PESSARIES
• CREAMS
• OINTMENTS
• GELS
George Tanaseanu, general manager of PSI
it requires a special authorization to perform, which creates an extra hurdle for
investors. This certification is the only
one of its kind in the European Union
and has essentially resulted in Romania
falling behind the Czech Republic and
Hungary where these requirements
are non-existent,” notes Bujor-Eugen
Almasan president of the Association
of the Companies Coordinating Clinical
Trials in Romania (ACCSCR).
With in excess of 10 top-ranking
CROs already present in Romania, one
might be forgiven for thinking that market could be nearing saturation, but this
is categorically not the case according
to the clinical research community.
“The market appears pretty crowded
if you count up the number of active
CROs, but closer inspection demonstrates that this is an illusion,” reflects
George Tanaseanu, general manager
of PSI. “The total number of ongoing
trials this year in Romania is 1714
compared to 4054 in Poland which can
be considered the CEE leader with its
comparatively larger population. More
revealing, however, is the disparity in
numbers of trials being conducted by
neighboring countries with smaller populations: Hungary, which is on 2556,
and the Czech Republic on 2818. These
places have less than half the population, but are managing to conduct double the trials. This means that there’s a
huge amount of slack in the market still
to be exploited. The cake is big enough
for everyone,” he attests.
“The Romanian market can be seen
as a local expression of global tendencies for pharmaceutical companies
to subcontract and externalize clinical trials over wide geographic footprints. With a market size and patient
profile of such magnitude, the country represents a natural candidate as a
destination country. The local market
is growing, the untapped potential remains deep and there is plenty of work
to do. There’s room for all of us: a rise
in tide floats all boats so to speak,”
acknowledges Badita.
CONTRACT
MANUFACTURING
• TECHNOLOGICAL TRANSFER
• ANALYTICAL DEVELOPMENT
AND VALIDATION
• SCALE-UP AND INDUSTRIAL
PRODUCTION
• R&D DEVELOPMENT
• PROCESS OPTIMIZATION
HEAD OFFICE:
82 A, Aurel Vlaicu Blvd.,
Constanta, Romania
+40 241 634 742
www.magistracc.com
47
COMPANY INDEX
Including list of advertisers
Advertisers
COMPANY NAME
PAGE #
AHK19
Amgen
21, 22, 23
Antibiotice Iasi
8, 9, 29
Association for Generics Manufacturers (APMGR)
26
Association for Innovative Pharmaceutical Manufacturers (ARPIM)
24, 25, 36, 37, 46
Association of the Companies Coordinating Clinical Trials in Romania (ACCSCR)
46, 47
Astellas22
Aurobindo29
BMS
8, 19, 23, 27, 36, 37, 46
Cegedim
7, 8, 19, 23, 24, 27, 31
Cipla29
Dr Reddy’s
29, 30, 40, 41
Enterprise Concept
17
Ferring
16, 24
Gerot Lannach
7, 19
Glenmark
26, 29
GSK
14, 22
IMF
19, 23
INC research
46
Indian embassy
29
J&J38
Janssen
25, 27, 38
Link Resource
38
Macleods29
Magistra C&C
28, 30
Medlife14
Medochemie26
Merck Serono
22, 30
Ministry of Health
10, 11, 12, 14, 15, 19, 20, 23, 32, 33
Ministry of Internal Affairs
12, 13, 27
MSD
20, 30
Muşat & Asociaţii
14, 15, 44, 45
Mylan
26, 42, 43
National Agency for Medicines and Medical Devices (NAMMD)
5, 7, 20, 32, 34, 35, 38
National Health Insurance House (CNAS)
13, 21, 23, 24, 32, 33
Pfizer
20, 30
PSI
46, 47
Regina Maria 14
Sanosan28
Serban and Musneci Associates (SMA)
14, 22, 25, 31
Tuca, Zbarcea & Asociatii
17
Zentiva
8, 9, 25, 26
48
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49
Photo © page 2: Mariuca Georgescu.
Photo © page 14-15: Flickr: cea +. Victor Brauner - Cosmogonie d’un visage (1961).
Photo © page 17: Flickr: Thomas Quine. Crowd.
Photo © page 34-35: Flickr: Nick Savchenko. Carpatians.
Photo © page 37: Flickr: Alexandru Panoiu. The Roman mosaic-floored edifice of Tomi.
Photo © page 39: Flickr: Andre BIANCO. Les Sables d’Olonne (85).
Photo © page 40: Flickr: fusion-of-horizons. stavropoleos.
50

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