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HEALTHCARE
HEALTHCARE
LIFE
SCIENCES
LIFE SCIENCES
REVIEW
REVIEW
PHARMACEUTICALS:
SHAKING UP THE SYSTEM
PHARMACEUTICALS:
HEALTH
POLICY
AT THE
PAGE
21
PHARMACEUTICALS:
SHAKING UP THE SYSTEM
FOREFRONT:
INTERVIEW
SHAKING
UP THE
SYSTEM
PAGE 21
WITH DR SUBRAMANIAM,
PAGE 21
MINISTER OF HEALTH
PAGE 4
&
CARVING OUT A MEDICAL
DEVICE MARKET
CARVING OUT A MEDICAL
PAGE 56
CARVING OUT A MEDICAL
DEVICE MARKET
DEVICE MARKET
PAGE 56
AN INTERESTING
PAGE 56
MANUFACTURING BASE?
PAGE 12
CONVERGENCE IN ACTION:
CASE STUDY: SILANES
FOCUS ON DIABETES
CONVERGENCE IN ACTION:
PAGE 70 CONVERGENCE IN PAGE
82
ACTION:
CASE STUDY: SILANES
FOCUS ON DIABETES
DENGUE
CASESANOFI’S
STUDY: SILANES
FOCUS ON DIABETES
PAGE 70
PAGE 82
PATROL LAUNCHES
MEDICAL TOURISM:
PAGE 70
PAGE JUST
82
NATIONWIDE
PAGE 22
A (FLIGHT) TICKET AWAY
PAGE 23
MEXICO
2013
MEXICO 2013
COFEPRIS
Revamped
COFEPRIS Revamped
Mikel Arriola, the man who changed an institution and an industry PAGE 18
Mikel Arriola, the man who changed an institution and an industry PAGE 18
Mikel Arriola, the man who changed an institution and an industry PAGE 18
CHAMPIONING HEALTHCARE
published in association with
published in association with
published in association with
HEALTHCARE AS A NATIONAL KEY ECONOMIC AREA PAGE 7
MALAYSIA
2013
2013
2013
January 2015
Brought to you by
2
Acknowledgements
PharmaBoardroom would like to thank
the Ministry of Health,
Dato Azman Mahmud the Ministry of Health, CEO, MIDA,
Yew Wei Tarng, President, PhAMA
Dr Mohamed Ali Abu Bakar,
CEO, Clinical Research Malaysia (CRM)
Tan Sri Dato’ Seri Dr. Robaayah Zambahari,
Chief Executive Director, IJN National Heart Institute
and
Alexander Stedtfeld, General Manager,
Malaysian-German Chamber of Commerce and Industry (MGCC)
for their support, assistance, and enthusiasm!
MALAYSIA JANUARY 2015
3
CONTENTS
Health Policy to the Forefront 4
Championing Healthcare 7
Partnering for Malaysia’ Success
8
Four Years Down the Road 8
Entry Point Projects for the Pharma Sector 9
Three Ethnicities, One Malaysia for Clinical Trials
12
Bringing Phase 1 to Malaysia 12
An Interesting Manufacturing Base? 13
That’s Halal, Folks!
14
Sea Cucumber: Natural, Halal and Conquering New Markets 14
Outsourcing on Your Own Doorstep 16
One Care Malaysia Strides Ahead 18
Invest in Malaysia’ Healthy Future 20
Can Malaysia Compete Regionally on Healthcare? 22
SANOFI’s Dengue Patrol Launches Nationwide
23
Medical Tourism – Just a (Flight) Ticket Away 24
Beating Heart Disease in Malaysia 26
Improving Malaysian Hospitals 26
Trials & Counting 28
CCM: Pharma’s Role in a Diverse Portfolio
30
The Future of Malaysian Clinical Research 32
This report was prepared by Pharmaboardroom.com
Project Director: Alina Manac
Project Coordinator: Valerie Baia
Contributions: Jessica Circi, Teddy Lamazere
Editor: Karim Meggaro
Project Publisher: Julie Avena
Graphic Assistance: Nisha Albuquerque, Rahli Omar
To read exclusive interviews and more info, please log onto www.pharmaboardroom.com or write to [email protected]
Copyright
All rights reserved. No part of this publication maybe reproduced in any form or by any means, whether electronic, mechanical or otherwise including
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While every attempt is made to ensure the accuracy of the information contained in this report, neither Focus Reports nor the authors accept any
liabilities for errors and omissions. Opinions expressed in this report are not necessarily those of the authors.
MALAYSIA JANUARY 2015
4 Exclusive interview with Malaysia’s Health Minister
Health Policy to the Forefront
Datuk Seri Dr. S. Subramaniam, Minister of Health of Malaysia
PharmaBoardroom: The Healthcare NKEA, under The Economic Transformation Program, has
been a success so far with the participation of international players. How is the Ministry of
Health (MoH) collaborating and helping international investors like Servier (EPP3) participate
in the development of pharmaceutical excellence in Malaysia?
DATUK SERI DR. S. SUBRAMANIAM: We have been quite successful in meeting the various targets
set for the Healthcare NKEA under the Economic Transformation Program. We will continue our
efforts to attract both local and international companies to participate in the Healthcare NKEA,
especially as lead organizations in the various EPPs. This will help grow the healthcare industry and
further encourage collaboration between the public and private sectors.
On June 28th, 32013, MoH signed a memorandum of understanding (MoU) with IMS Health Malaysia.
This MoU facilitates the sharing of the pharmaceutical database for the public sector with the private
sector. The MoH is able to tap into IMS’s pharmaceutical database on the private sector while IMS
can access the MoH’s pharmaceutical database as well.
EPP3 saw strong interest from private sector players in the field of respiratory medicine. Four project
owners have come forward with plans to manufacture respiratory products, such as metered dose
inhalers and dry powder inhalers. It has been announced that these four projects are being
implemented.
Malaysia is committed in the development of pharmaceutical excellence for the country. Recently,
on the 23rd and 24th of September, 2014, the prime minister chaired a Bio International Advisory
Panel meeting in New York City, USA. Deliberations were focused on Bio-Economy Development
programs as well as on technology bridging between bio-based companies and international research
and development institutions.
The introduction of an Off-Take Agreement scheme under EPP3 has generated much interest for
both MNCs and local pharmaceutical companies. This initiative has provided some assurances of
market access for public sector purchase as well as facilitating exports of these products as these
manufacturers have a record that the Malaysian government is purchasing and using their products,
thereby providing confidence to the export market of the safety and efficacy of these pharmaceuticals.
Under the Healthcare NKEA, a monthly steering committee meeting is held that is chaired jointly by
the minister of health and minister in the PM’s department overseeing the performance management
MALAYSIA JANUARY 2015
5
& delivery unit (Pemandu). The steering committee meeting also serves as a problem-solving
meeting, where various parties, including those from the private sector can raise issues to be resolved.
Industry organizations from the pharmaceutical industry, such as the Pharmaceutical Association of
Malaysia, whose memberships are mainly from the MNCs, are represented on the Steering committee.
This forum has certainly facilitated both MNCs and local pharmaceutical companies to achieve the
goals of EPP3.
PB: The industry has been voicing positive comments about the participation and support of
the Ministry of Health in Malaysia. How are you planning to remain a true partner to the
industry?
DATUK SERI DR. S. SUBRAMANIAM: Malaysia is taking steps and moving forward to build a good
partnership within the industry. One of the targets for 2014 is the introduction of Off-Take Agreement
incentives for Medical Devices under the Healthcare NKEA. This OTA agreement for Medical Devices
has similar features with the OTA for pharmaceuticals. This is one way forward to further build
collaboration with the industry.
“The Malaysian Government continuously strives to provide a
business-friendly environment for the private sector in which to
operate. These efforts have been affirmed by the World Bank,
which ranked the country 6th best location in the world in which to
conduct business in its Doing Business 2014 report. The World
Bank’s competitiveness criteria in the Doing Business ranking
include ease of starting a business, licensing approvals, tax
administration efficiency, and ease of cross-border trading.”
The MOH has also taken the initiative to undertake a business process reengineering a review to
reduce bureaucracy and improve efficiency for stakeholders that conduct business with the Ministry,
whether for permits or licenses. On this note, out of a total of 89 licenses/approvals that are granted
by the Ministry, we have done away with two, while 11 were composited into seven. For the remaining
seven licenses/approvals, improvements were to shorten the time taken for processing them.
Moreover, for ease of submitting applications, it can be made online.
The country has also taken measures to ensure the security of foreign investments, signing on to
Investment Guarantee Agreements (IGA) with 58 countries, including members of the Association
of Southeast Asian Nations (ASEAN), and the Organization of Islamic Cooperation (OIC). These
agreements protect foreign companies against nationalization and expropriation; they ensure prompt
and adequate compensation in the event of nationalization or expropriation, and assurances on free
transfer of profits, capital and other fees.
The MoH will continue to work closely with relevant agencies to address coordination and
implementation issues in the healthcare sector as well as engaging with private sector stakeholders
to better understand their needs and remain a true partner to the industry.
MALAYSIA JANUARY 2015
6
MALAYSIA JANUARY 2015
pharmaboardroom.com
7
Special SponSored Section
Malaysia report
MALAYSIA:
Championing
Healthcare
Credits: Ong Yong Da, 17. Ong has limited speech, yet is armed with a cheerful smile. He participates in many
exhibitions locally and internationally in the “Special Artist” category. Courtesy: Deloitte Malaysia
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“One
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vices and supporting collaborative
was produced by Pharmaboardroom.
efforts between public and private
healthcare
providers.”
Project Director:
Alina Manac
The
private
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Valeriecurrently
Baia
counts
for
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percent
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Contributions: Jessica Circi, Teddy Lamazere
total
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Editor:
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healthcare
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place
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Graphic Assistance: Nisha Albuquerque
on access, according
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Rahli Omar WeiTarng, President of PhAMA, MaFor exclusive
interviews for
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laysia’s
association
innovators:
log onto
www.pharmaboardroom.com
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innovative drugs.”
JanUarY 2015JANUARY
FOCUS REPORTS
MALAYSIA
2015S2
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Partnering for Malaysia’s success
Servier was one of the first multinational
companies to take part in an Entry Point Project (EPP). “The NKEA program, coupled with
Malaysia’s PIC/S certification, show that Malaysia is ready to blossom and compete with
any consolidated hub in Southeast Asia in the
near future,” says Servier Malaysia’s general
YB Dato’ Seri Dr.
manager Glen Lingam.
S. Subramaniam,
Malaysia has long been in the shadow of
Minister of Health
other Asian hubs when it comes to healthcare, most notably from its neighbour Singapore, but also countries like Taiwan and
South Korea. As a result, much investment
naturally flows to these other hubs. “It is true
that not many MNCs are participating to the
government’s healthcare NKEA and EPPs,”
Lingam admits. “This must change, as local
companies have great capabilities to offer,
and it is important to contribute to the sucGlen Lingam,
cess of government programs such as the
General Manager,
healthcare NKEA. Not only are we increasing
Servier Malaysia
GNI, we are also creating new job opportunities and helping Malaysia become a high
value manufacturing nation.”
“The ministry has been working toward attracting more private
companies to invest, in line with the desire of the government to
make the sector more dynamic, strong and competitive,” says YB
Dato’ Seri Dr. S. Subramaniam, Malaysia’s minister of health. “By
working together, I am confident that we will be able to deliver an
effective and responsive healthcare system that will benefit all Malaysians. Indeed, I am confident that we can truly become a nation
working together for better health.”
Under the agreement, Servier will transfer the technology for
Diamicron MR 60mg to local manufacturer Kotra Pharma, and explore the opportunity to export locally manufactured Vastarel MR
35mg to countries in South Asia and also for supply to the public
sector in Malaysia. This project is expected to augment Malaysian
GNI by USD 12.43 million by 2020, and create seven new jobs. This
technology transfer is one of 36 projects launched under the healthcare NKEA between 2010 and December 2013 that the Malaysian
government hopes will add USD 2.06 billion to the country’s gross
national product, create 26,476 new job opportunities and add new
investment opportunities worth USD 1.5 billion in total by 2020.
“The reception of healthcare NKEA by the private sector continues to be promising,” continues the minister, “as healthcare NKEA
continues to nurture the industry by encouraging the participation
from the private sector.” Lingam believes that the opportunities for
multinationals in Malaysia are promising, a message reinforced by
Servier’s participation in the country’s development program. “I truly encourage others to join hands and take part into the healthcare
NKEA,” he says. “Every player in the industry has a role to play for
the development of the country.”
S3MALAYSIA
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JanUarY 2015
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2015
This dual system may not be sustainable for much longer. “There are
concerns in terms of financing the
system and whether we should maintain our current dual public private
system,” explains Dato’ Dr. Noor
Hisham, director general of health at
the Ministry of Health. “We know
Dato’ Dr. Noor
for sure that in the long run our curHisham, Director
rent system is not sustainable.”
General of Health,
Increased collaborative efforts
Ministry of Health
between public and private healthcare providers will be a great source
of growth for the pharma sector, according to Zarif Munir, partner and
managing director of Boston Consulting Group Malaysia. “As companies who provide private healthcare insurance start to see the logic
of partnerships with hospitals and
pharmaceutical companies, it’s only
Leah Goodman,
Managing Director,
going to increase the willingness of
Sanofi Malaysia,
the consumers to buy branded and
Singapore and Brunei
innovative products. This is what
makes Malaysia a very attractive market for originators
who have innovative solutions.”
Four years down the road
How successful has the healthcare NKEA been so far?
“The NKEA has transformed the Malaysian healthcare
sector, bringing a set of opportunities for many stakeholders,” opines the president of PhAMA. However, he
believes more needs to be done in order to increase the
effectiveness of the NKEA. “In order to boost EPP 2 and
3 we need to have the right incentives in place, which have
not been present so far. This means better tax incentives,
faster regulatory approval and innovative medicine funding.”
But so far, the concrete investments that have come as a
result of the NKEA have been impressive, as Dato’ Azman
Mahmud, CEO of the Malaysian Investment Development
Authority, explains: “Based on MIDA’s Investment Performance Report, investment in the pharmaceutical industry
(2011-2013) under EPP 3 was USD 340 million with domestic investment of USD 164 million (46.9 percent) and
foreign investment of USD 176 million (53.1 percent).”
“We have been quite successful in meeting the various targets set for the healthcare NKEA,” states the
Health Minister. “We will continue our efforts to attract both local and international companies to participate in the healthcare NKEA, especially as lead organi-
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9
Entry Point Projects for the Pharma Sector
By 2020, the healthcare NKEA aims to generate USD 10.15
billion in GNI and create 181,000 new jobs. Below are the
highlighted entry point projects (EPPs) under the NKEA that
impact most the pharmaceutical sector.
From left: Tan Sri Dato’ Seri Dr. Robaayah Zambahari, Chief Executive
Director, IJN National Heart Institute; Dato’ Azman Mahmud, CEO,
Malaysian Investment Development Authority; Yew Wei Tarng,
President, PhAMA
zations in the various EPPs. This will help grow the healthcare
industry and further encourage collaboration between the public and private sectors.”
Leah Goodman, Sanofi’s general manager in Malaysia, Singapore and Brunei concurs. “Malaysia is a priority for Sanofi and we
are doing everything we can to keep this priority status.” Not only
is the French drugmaker involved in EPP3 through a partnership
with local company Hovid, they have also been working with the
government in anticipation of the launch of their breakthrough
dengue vaccine. “ In 2012, Sanofi launched a program named
“Dengue Patrol” in collaboration with the Ministry of Health and
Ministry of Education. This program played a significant role with
school children located in dengue hot spots, where we must main-
magenta
cyan
yellow
black
EPP 2: Creating Supportive Ecosystem to Grow Clinical
Research
1,000 clinical trials per year targeted by 2020. Aims to set up
of more clinical research centers, develop more clinical practice-certified investigators and improve approval timelines.
EPP 3: Malaysian Pharmaceuticals – Increasing Local Generics Manufacturing for Exports
Aims to help upgrade local manufacturing plants, develop
strong ties between MNCs and local manufacturers, establish off-take agreements with the Ministry of Health, and
have more comprehensive national pharmaceutical data
EPP 4: Reinvigorating Healthcare Travel
Phase 1: Growing patient volume through extensive marketing, cross-border alliances and enhanced customer
experience
Phase 2: Investing in better infrastructure and specialist capacity to shift towards more profitable in-patient care
Sanofi HP Artwork_1-1.pgs 12.12.2014 19:23
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MALAYSIA JANUARY 2015
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tain the information and an extremely
high awareness level.” explains Sanofi’s
Goodman. “The Ministry of Health and
Ministry of Education have been crucial
elements in raising awareness and keeping
everyone alert. Government stakeholders are fundamental for the successful
launching of the dengue vaccine.”
three ethnicities, one Malaysia For clinical trials
“Today, around 20 percent of trials are
done in public hospitals and our objective is to reach at least 30 percent this year
and in the near future 50 to 60 percent.
Clinical trials represent a national priority and we are proud to be the catalyzer
of this goal.”, explains Chua Hong Teck,
the director of the Healthcare NKEA at
PEMANDU, the unit charged with overseeing the implementation of the NKEAs.
“Malaysia has a unique advantage
over other countries: its ethnicity base,”
says Leonard Ariff Abd. Shatar, acting
Source: National Pharmaceutical Control Bureau
From left: Rhenu Bhuller, Senior VP Healthcare,
Frost & Sullivan Malaysia; Alan Ong, Executive
VP for the Asia Pacific Region for INC Research
CEO of CCM Berhad, a large local company, when asked about clinical trials.
“Therefore diverse patient recruitment
is possible in Malaysia with a community comprising people of Malay, Chinese
and Indian extraction. This Asian DNA
present in Malaysia allows companies to
concentrate trials in Malaysia instead of
having to pursue various trials in various
countries, resulting in possible savings.”
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However, not everyone is as optimistic about this fact as
Shatar. “I don’t believe that we are able to become a clinical trial
hub because while we are ethnically diverse, the size of populations for each is not equal,” admits Rhenu Bhuller, senior VP in
charge of healthcare for Frost & Sullivan Malaysia. “While the
Malaysian society is diverse, the overall population is still too
small to be relevant.”
“The Malaysian government is incredibly supportive of clinical trials,” says Alan Ong, executive VP for the Asia Pacific region for INC Research, a CRO, but explains that concrete advancements are needed. “Whilst the vast growth potential for
clinical trials in Malaysia is very clear, the country is in need
of additional talented professionals to conduct clinical research.
Malaysia, like most areas where clinical development is on the
rise, is in need of an influx of investigators, monitors and other
research professionals.”
an interesting ManuFacturing base?
Under EPP 3, the Malaysian government initially set out just to
promote generic manufacturing, but has recently expanded its
mandate to look at OTC, supplements, biologics and vaccines,
in order to boost its export platform. “The priority should be
to focus on manufacturing value added products, and we must
InFo KInetIcs,
your cRo of choice.
Better - Greater - Faster
Info Kinetics
www.info-kinetics.com
S7 FOCUS REPORTS
JanUarY 2015
MALAYSIA JANUARY 2015
also focus on being early into certain fields like biologics, for
example,” opines Tan Sri Dato’ Dr. Abu Bakar Suleiman, president of Malaysia’s International Medical University. “A country will not become developed and advanced if it focuses on
low cost manufacturing and basic healthcare. We need to take
Malaysia to the next level and the government will play a big
role in this journey to excellence.”
Bringing Phase I to Malaysia
In the last three years, Malaysian CRO/
SMO Info Kinetics has grown at an
impressive rate. One of the keys to
this has been the decision to house
a centralized 25,000ft2 facility at the
Gleneagles Hospital Penang, which
has given the company the space for
Dr. Lee Toong Chow,
international expansion. The vision of Managing Director,
the founder, TC Lee, is to use the in- Info Kinetics
ternational model as a benchmark for
the company, since its inception in 2001. Today IK is the
partner of choice to some of the leading international biopharmaceutical companies. As the company’s clients move
their focus to Asia, IK aims to connect them to the best regional opportunities.
“Being closely associated with an international hospital
such as Gleneagles and encouraged by Dr Lim Cheok Peng,
ex-MD of Parkway-Gleneagles, provides me the passion and
confidence to excel beyond our shores,” says adjunct associate professor Toong-Chow Lee, managing director of Info
Kinetics and University of Queensland.
“Secondly, the US FDA has recently inspected our facilities and uplifted our image with further accreditation. This is
a key advantage for us as we are the only early phase CRO/
SMO in Southeast Asia that has been inspected by major
international agencies - Germany, France and the US. This
has resulted in a larger stream of international studies from
Europe, North America, India, Taiwan and Japan.”
It is a point of pride for countries to be able to attract
Phase I trials – the sign of a well-developed research base.
“Phase I trials are definitely an area where Malaysia stands
behind compared to other countries in Asia Pacific,” admits
Lee, “but it is only a matter of time until this improves, thanks
to Malaysia’s well-established regulatory system, infrastructure, bio-diversity and multi-ethnicity population, As a member of the ASEAN committee and technical chair for BA/BE
task force, we are able to share our experience with member
countries to achieve ASEAN harmonisation.”
“With Malaysia taking over the ASEAN chair as well as a
friendly business environment, I am sure more companies
from the West will use Malaysia as their gateway and platform to ASEAN. In fact, IK has begun the journey to link smart
and strategic partnerships,” Lee concludes.
Special SponSored Section
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13
Malaysia report
According to PEMANDU, pharmaceutical exports grew by 8 percent between
2012 and 2013, with an export value of
USD 187 million, but Big Malaysian manufacturers still struggle today to make exports a major part of their turnover. “Our
exports represent 11 percent of our total
revenues,” explains Leonard Ariff Abd.
Shatar of CCM. “Malaysia still has man- Tan Sri Dato’
ufacturing plants from the 1980s; it does Dr. Abu Bakar
Suleiman, President
not show an image of modernity and high of Malaysia’s
standards even though many of the players International
have invested in new equipment and new Medical University
greenfield facilities in order to maintain
quality manufacturing standards. We need to have a local industry effort to raise our standards and show to the rest of the world
that Malaysia is advanced in terms of manufacturing assets and
ability to meet all necessary international standards.”
One way to improve exports is through government intervention. “The introduction of an Off-Take Agreement scheme under EPP 3 has generated much interest for both MNCs and local
pharmaceutical companies,” explains Minister of Health Subramaniam. “This initiative has provided
some assurances of market access for public sector purchase, as well as facilitating
exports of these products, as these manufacturers have a record that the Malaysian
government is purchasing and using their
products, thereby providing confidence to
the export market of the safety and efficacy
of these pharmaceuticals.”
Sanofi is one MNC that has partnered Leonard Ariff Abd.
with a local manufacturer to boost its Shatar, acting CEO,
CCM Berhad
Malaysian domestic production. “Local
manufacturers are going to become more and more attractive to
MNCs, especially for those wanting to properly enter the public sector,” says Sanofi’s Goodman, managing director of Sanofi
Malaysia, Singapore and Brunei. Today, Malaysia is Sanofi’s
largest country in terms of generics production in Asia. “We
know that other MNCs in Malaysia have tried making a success
of their own generics without significant sustainability, so we can
be proud of our achievements so far.”
ing and molecules present in original patented formulas. Since
quite a few innovator products have porcine or other kind of animal molecules, it has been a challenge on our side to develop halal generic equivalents and source raw materials that meet strict
Halal guidelines. Halal will become the next differentiating standard in generics and market demand will dictate what manufacturers do, so CCM is proud to be a pioneer in this field At the end
of the day, only doctors and pharmacists dispense medications to
patients in Malaysia, so all we are hoping for is that they allow
patients to have access to information and to exercise their rights
to choose from the alternatives available which would include
halal medications.”
Nashmir Capsule is
a halal-only producer,
which Dato’ Kadhar
Shah Abdul Razak,
the company’s managing director, believes
gives them an advantage over traditional
pharma
companies
trying to move into halal. “Being a company Dato’ Kadhar Shah Abdul Razak,
Managing Director, Nashmir Capsule
focused on gelatin cap-
that’s halal, Folks!
With the global halal medicines market estimated at around USD
34 billion in 2013, Southeast Asian countries like Malaysia and
Indonesia, along with the Middle East, have a natural advantage
in this arena because of strong domestic markets.
“We like to believe that in the sea of generics, halal is a true
differentiator,” says Leonard Ariff Abd. Shatar of CCM. “When
speaking about halal, ethical issues arise because of animal test-
JanUarY 2015
FOCUS REPORTS S8
MALAYSIA JANUARY 2015
14
pharmaboardroom.com
Special SponSored Section
Malaysia report
sules, you can see how we can stay true to halal principles, as it
is all about the animal bone used to produce our products and
this can obviously be controlled. This is how we can provide our
halal guarantee. I can say with confidence that the demand is
constantly increasing and our plants are struggling to keep up
with customer need.”
Razak explains that being a Malaysian company has its advantages in other markets. “As a Malaysian company, we are not
requested to pay taxes within ASEAN countries. So for example
it would be more expensive for companies in Korea, China or India to enter this market. Also, the reputation of Malaysian products, which stand for quality, might have helped. Overall, I can
say that the market demand is very good not only within Malaysia but amongst ASEAN markets too. And once we consolidate
our presence here, we will surely look to expand further.”
outsourcing on your own doorstep
“As a global services location, Malaysia is third in the world behind India and China,” explains Kana K Thamby, CEO of GCI,
a healthcare IT company, but business process outsourcing has
not been widely adopted by the Malaysian industrial base to date.
“One of the things we do here in Malaysia is post-implementation support, which lends to the overall healthy BPO environ-
Sea Cucumber: natural, halal,
and conquering new markets.
“In 1989, I noticed an ancient trend coming back amongst the Malaysians that
saw people using boiled gamat—one of
23 species of sea cucumber present in
Malaysia—as a remedy for injuries and
pain,” explains Professor Dato’ Dr. Has- Dato’ Dr Hassan Bin
Yaacob, Executive
san Yaakob, executive chairman of Heal- Chairman, Healwell
well. The initial research Yaakob con- Pharmaceuticals,
ducted led to a scientific breakthrough Malaysia
that was awarded first prize at Malaysia’s National Scientific Awards, and eventually, a product—
Gamogen. “One of the most successful markets where our
products are currently marketed is Indonesia, with a great
response from consumers and impressive sales volume. Our
next step will be to set up ‘House of Healin’ in Indonesia,
giving patients direct access to our products.” says Yaakob.
“Another country I am looking at is Saudi Arabia, and the
United States, which would come naturally after the UAE. Our
recent obtainment of Halal certification, which has become
an anchor for the marketing of our products here in Malaysia,
will definitely be of great help when entering these markets
as well. The only minor concern I had initially is related to production: our factory here may not be able to cope with such
expansions. But I am already considering different platforms
overseas and I am confident we have exciting times ahead.”
ment”. GCI operates in multiple geographical locations across
the world and has experienced a wide range of BPO environments and healthcare systems. But how can
this experience be brought back to Malaysia? “We hope that Malaysia continues to
implement more and better systems to help
serve the patient base here,” says Thamby.
“It’s definitely more exciting to be here in
a developing market where you have more
opportunities, despite the increased challenges of a young and developing market.”
Kana K Thamby,
Thamby believes that the biggest hurdle Chief Executive,
in implementing BPO processes in the Ma- GCI MSC, Malaysia
laysian healthcare sector is budget. “It’s not
so much a lack of desire to do it; the funding is just not there
yet. Perhaps the formula needs to be changed. I think the national health insurance program is the right way to go, where
the burden of the healthcare costs in the country are shared by
the employer, the government and the patient. With this type of
model there is more accountability and it reduces the burden of
spending all the money on reactive care: funds can be more effectively allocated towards proactive care as well. It’s just a matter
of time.”
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MALAYSIA
2015
S9 FOCUS
REPORTSJANUARY
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Info Kinetics
Bioanalytical Services
BA/BE Studies
Ethnic Bridging
Studies
Analytical Method
Validation
Clinical
Outsourcing
And Contract
Research
Contact us at:
Tel: +604-228 5760 Fax +604-228 5715
Info Kinetics Sdn Bhd / Clinical Research
Centre, Gleneagles Penang, 5th Floor, 1
Jalan Pangkor, 10050, Penang, Malaysia
www.info-kinetics.com
Phase I, II, III
Pharmaceutical
Testing
MALAYSIA JANUARY 2015
16 Interview
One Care Malaysia
Strides Ahead
The director general of health at the Ministry of Health explains
the need for a solid plan for the development of universal coverage in Malaysia, and how the country’s One Care Malaysia plan
is progressing in its implementation.
PharmaBoardroom: The Malaysian government has been pushing for the
development of One Care in Malaysia.
Can you tell us about the prospects of
this system and the benefit for
patients?
DATUK DR. NOOR HISHAM: Our vision
is to have the public and private sector
working together, with the patient as
the main focus. The private sector has
done well so far, contributing to 4.6
percent of GDP, whereas the government is only spending 2.6 percent of
GDP. In order to bridge the gap, One
Malaysia Care system is the solution
and what we have been working on for
many years.
While the private sector has excellent facilities and services given their
high financial resources, they lack in
terms of teamwork or collaborations
and don’t perform training or research.
For One Care Malaysia to work we need
to change this. On the other hand, the
public sector has limited resources and
an overly large number of patients.
While the poor use the public sector
for obvious financial reasons, we are
also seeing patients from the private
sector moving to the public and this is
creating huge queues.
PB: In order to bridge this gap and
bring together the public and private
sector, what should be the focus?
DATUK DR. NOOR HISHAM: For One
Care Malaysia, we have engraved four
fundamental pillars of success: quality,
accessibility, affordably and equity.
These four pillars are to be combined
in different phases, which are to be
implemented over time.
Stage one is strengthening the public healthcare system. We must upgrade
all infrastructure and equipment like we
have with some of the new public clinics or hospitals like Putrajaya hospital.
Also, we must provide proper training
to our medical staff and ensure that we
retain the best doctors in the public
sector. While many decide to go to the
private sector for financial purposes, we
are working through this issue through
our specialist program retention. While
we don’t offer a similar salary, we offer
incentives, research, training and conferences. We of course believe in flexibility so we would allow public doctors
to perform in private hospitals on the
weekends for example. We will focus
on corporate culture, team work, fun
working environment and professionalism in order to create the best conditions for doctors to work and stay in the
public sector. We are also working on
Datuk Dr. Noor Hisham, DIRECTOR GENERAL OF HEALTH, MINISTRY OF HEALTH
MALAYSIA JANUARY 2015
17
a new outcome base reward system, where
the doctors will be rewarded by the number of patients they attend and treat successfully. For sure this system will motivate
our doctors.
PB: One of the main issues with public hospitals is dealing with queues and excessive
number of patients. How do you intend to
resolve this?
DATUK DR. NOOR HISHAM: To decongest
our hospitals, we must also reengineer our
services. Sometimes this means something
as simple as helping customers pick up their
prescribed medicine by installing a drivethrough at the hospital or send the medicines
directly to their home in order to avoid long
queues at the hospital. Another example is
the current issue we have with fulfilling
300,000 cataract surgeries a year. While our
37 hospitals can perform around 10,000 cataract surgeries, our idea is to work in partnership with other agencies that have facilities
and are able to fulfill high quality cataract
surgeries. One center is capable of doing 30
operations a day or 10,000 per year; this is
why there are indispensable to us. Some centers are capable of doing a cataract surgery
for RM 103 (USD 33).
We know that one critical factor to
reduce the financial burden will be to significantly reduce hospitalization time for
patients. We are therefore incorporating
the pain free hospital concept where for
instance every surgery has to be little invasive by performing keyhole surgery.
PB: Reducing the burden on healthcare is
a priority for governments worldwide.
How is One Care Malaysia financed and
what can we expect on the long run in
terms of financing?
DATUK DR. NOOR HISHAM: Integrating
primary and secondary care is at the base
of One Care Malaysia and the only way to
reduce financial burden. While today we
operate on a curative system, we must
move towards a stronger preventive sys-
tem. Not only will this generate huge savings, it will also help to save many lives. This
is the only way to reduce the incidence of
diabetes and hypertension.
While we know that affordability is fundamental, we must start looking at new
ways to finance our system to ensure the
prosperity of our Malaysian healthcare system. Hence, we have no other option but
to start charging local and foreign patients
for the actual cost of treatment or operation. Foreigners will have to pay full out of
pocket price or through their private insurance. Locals will also have to pay but the
difference is that the government will be
reimbursing. We don’t have any information regarding the level of reimbursement
yet but we will be evaluating the best
options in the next three years. And of
course for the poor patients, they will have
100 percent full reimbursement. Many
questions still arise in terms of premium
and exactly what treatment will be covered,
but it is fundamental for everyone to understand that this whole process of setting the
foundations needs time.
PB: What can you tell us about Malaysia’s
goal to still remain a reference in terms of
healthcare quality and implement Universal Health Coverage?
DATUK DR. NOOR HISHAM: The best hospitals in the world are at the forefront in services, research and training. If we are able to
implement this in private Malaysian hospitals,
we can be certain that Malaysia will remain
among the best worldwide healthcare providers.
While many speak of implementing Universal Health Coverage UHC in the future,
I would like to reply that UHC is already in
place in Malaysia and WHO has already recognized Malaysia with UHC. While we are
aware that UHC is perfectly implemented
in our public sector, now we must transfer
it to the private side and One Care Malaysia will be the key to this transition.
MALAYSIA JANUARY 2015
18 Interview
Invest in Malaysia’s
Healthy Future
The CEO of MIDA, Malaysia’s investment agency, discusses Malaysia’s potential as a pharma manufacturing hub.
PharmaBoardroom: In the past years
Malaysia has seen a flow of new manufacturing projects (GSK, Novartis) and
joint ventures. What challenges do you
see to further develop these investments
and collaborations?
DATO A ZMAN MAHMOUD : It is
expected that more international manufacturers will look at the opportunities in
cooperating with local established manufacturers through strategic partnership to
manufacture their products locally. We
know that it makes sense for MNCs to
come into Malaysia and use the existing
capabilities of local manufacturers.
We have also been advising the government on setting up the right environment for investors. For instance, regulations in the pharma industry must be
transparent and coherent with international standards to make Malaysia an
attractive place for long term settlement.
But also, companies must find attractive
financial incentives as many companies
today are looking at reducing costs when
looking for places to manufacture and
conduct clinical trials.
PB: Could you give us an overview of the
incentives offered to foreign and local
investors?
DATO AZMAN MAHMOUD: Many incentives exist in Malaysia and target a wide
array of elements and stakeholders. These
target manufacturing companies, high
technology companies, strategic projects,
Dato Azman Mahmoud, CEO, MIDA
MALAYSIA JANUARY 2015
special funds, exports, services, R&D,
import duty exemptions, fiscal and nonfiscal incentives.
For manufacturing companies a (PS)
Pioneer Status has been implemented
with income tax exemption of 70 percent
or 100 percent on statutory income for a
period of 5 years or also the option of an
(ITA) Investment Tax Allowance of 60 percent or 100 percent on qualifying capital
expenditure incurred for a period of 5
years. For the production of pharmaceuticals/medicaments which involves mixing
and blending activities, normal PS or ITA
is granted if the company undertakes
R&D activities with expenses amounting
to at least one percent of annual gross
sales.
Also, the government is offering a
(DISF) Domestic Investment Strategic
Fund of RM 1 billion (USD 310 million) to
accelerate the shift of Malaysian-owned
companies in targeted industries to high
value-added, high technology, knowledge-intensive and innovation-based
industries. This fund is for manufacturing
and services companies with Malaysian
equity ownership of at least 60 percent.
PB: Which factors are currently limiting
manufacturing expansion?
DATO AZMAN MAHMOUD: Countries
in Asia such as India, China, Korea and Taiwan are recognised as the leading manufacturers regionally, producing and export-
19
ing a large number of drugs in bulk, as well as
in dosage forms, to the more developed countries. Global competition will intensify, as these
major generic manufacturers in the region
increase their efforts to expand their presence
in emerging markets. Competition also arises
from MNCs, which acquire companies manufacturing generic products in these countries.
Given the limited domestic market, there
is a need for local manufacturers to venture
into export markets, as part of their growth
strategy. The industry will need to adopt
effective measures to enhance their level of
efficiency and reduce costs of production.
The domestic market is also expected to
face further competition from imports, as a
result of trade harmonisation efforts and
mutual recognition arrangements (MRAs)
with trading partners, especially ASEAN
countries. To facilitate and enable Malaysian
manufacturers to compete on fair grounds
internationally, efforts are needed to reduce
and eliminate non-tariff barriers, which
impose complex or ambiguous requirements
or certifications, labelling, packaging and testing.
PB: What is Malaysia’s main competitive
advantage when facing consolidated hubs
like Singapore and Taiwan or very populated
countries like Indonesia and the Philippines?
DATO AZMAN MAHMOUD: Malaysia is strategically located in the heart of South East
Asia and offers a cost-competitive location
for investors intending to set up offshore
operations for the manufacture of advanced
technological products for regional and international markets. The infrastructure in Malaysia is designed to serve the business community; it is one of the best in Asia.
Telecommunications network served by digital and fibre optic technology, five international airports (all with air-cargo facilities),
well-maintained highways and seven international seaports make Malaysia an ideal springboard to the Asia-Pacific market. With a combined population of 600 million and gross
domestic product of USD 1.8 trillion (RM5.68
trillion), the ASEAN market offers immerse
trade opportunities.
Malaysia offers investors a young, educated, productive and cost competitive workforce, which makes Malaysia highly attractive
in Asia. Backed by the Government’s continued support of human resource development
in all sectors, the quality of Malaysia’s workforce is one of the best in the region. Literacy
levels are high and school leavers entering
the job market have at least 11 years of basic
education. Also English is widely spoken as a
language in the country.
To this day, there are 20 public and 21 private universities and as well as more than 400
colleges, polytechnics and industrial training
institutes that offer courses leading to certificate, diploma, degree and post-graduate
degree qualifications. Courses related to
pharmaceuticals such as pharmacy, microbiology, biotechnology, biochemistry, and biomedicines are being offered by several public universities and private institutions of
higher learning, which includes: Universiti
Malaya, Universiti Sains Malaysia, Universiti
Kebangsaan Malaysia, and so on.
Finally Malaysia has a wide availability of
supporting facilities which include research
institutes such as the Institute for Medical
Research (IMR) and Malaysian Institute of
Pharmaceuticals & Nutraceuticals (IPHARM).
Also, for clinical trials we benefit from the Clinical Research Centre (CRC), comprising a network of 27 centers nationwide, acts as the
one-stop-centre by providing a single point
of contact to access all Ministry of Health hospitals and clinics to conduct clinical trials in
Malaysia. And finally we offer high technology and science parks like the Technology
park of Malaysia or the Penang Science Park.
MALAYSIA JANUARY 2015
20 Interview
Can Malaysia Compete
Regionally on Healthcare?
The president of PhAMA offers his perspectives on the implementation of Malaysia’s healthcare NKEA, and how Malaysia compares on a regional level as a healthcare hub.
PharmaBoardroom: With the introduction of healthcare as one of the
12 National Key Economic Areas
(NKEA) for Malaysia, great developments have come forward in the last
four years. Could you share with us
the strong points of this implementation?
YEW WEI TARNG : The NKEA has
transformed the Malaysian healthcare
sector, bringing a set of opportunities
for many stakeholders. Through the
NKEA were developed a multitude of
specialized programs called Entry Point
Projects (EPPs). Two of them, EPP 2 and
EPP 3, have set new ambitions for clinical research and local manufacturing
in Malaysia; both are fundamental to
the development of healthcare in
Malaysia.
PhAMA is very active in EPP 2, representing innovative companies investing in clinical research. Under EPP 2,
clinical research has been expanding
rapidly as a key program under the
healthcare NKEA. In fact, it has been
outperforming and exceeding initial
targets. At the moment we can count
over 300 clinical trials in Malaysia.
In order to boost EPP 2 and 3 we
need to have the right incentives in
place, which have not been present so
far. This means better tax incentives,
faster regulatory approval and innovative medicine funding.
The NKEA programs are well aligned
Yew Wei Tarng, PRESIDENT, PHAMA
MALAYSIA JANUARY 2015
with the government’s 11th Malaysian
plan (2016 -2020 ) to boost various
industries and grow the economy.
PB: What do you believe to be the current challenges and opportunities for
pharmaceutical CEOs in the Malaysian
pharma market?
YEW WEI TARNG: One of the main challenges is market access or the timely
access of innovative drugs to patients. In
Malaysia, 60 to 70 percent of patients go
to public hospitals; so if the drug is not
listed in public hospitals, the patient does
not get access to these innovative drugs.
Intellectual property is also a key
issue for pharma companies and needs
attention as it encourages innovation.
The government needs to emphasize this
for more and better innovative drugs to
become available.
In terms of opportunities, the pharma
market is growing at a fast rate and medical tourism is becoming a real asset for
Malaysia. The government has an EPP
dedicated to medical tourism and such
program will attract more patients to
Malaysia. If we want to promote medical
tourism, it also ties in well with getting
access to innovative medicines, as foreign
patients demand the best drugs available.
In order to attract medical tourism,
the government is giving tax incentives
that should allow more private hospitals
to adver tise and at trac t overseas
patients.
21
PB: How does an increasing national
income, shifting disease profiles, and ageing population affect pharma companies?
YEW WEI TARNG: We believe that companies in Malaysia are facing similar challenges
to the most developed western countries.
Obesity, diabetes, heart disease, neurodegenerative diseases and cancer are common
here, but are expanding fast.
The government has set up a network of
clinical research centers under the National
Institutes of Health (NIH) and Ministry of
Health where investigators and companies
can perform their clinical trials. With over 27
branches at major hospitals, clinical trials
facilities and infrastructure is still available to
attract more international companies to
Malaysia.
In the end, with the government’s will to
achieve a higher level of clinical trials, we shall
see many positive outcomes.
PB: What are the main competitive advantages of Malaysia among Southeast Asian
countries?
YEW WEI TARNG: Malaysia is attractive
because we have different ethnic groups:
Malay, Indians and Chinese. We also boast
excellent infrastructure, healthcare institutes
and hospitals where clinical trials are carried
out, with high level medical and clinical trial
investigators.
The government is also aiming for a more
competitive edge of Malaysia’s industry base.
With the advantage of having a wide range
of ethnicities, skilled labor and English speakers, Malaysia is an attractive place to conduct
business. With a strong base of local manufacturers the government is encouraging foreign companies to work with local companies
and develop contract manufacturing. The
government will offer incentives to foreign
companies partnering with local manufacturers using Malaysia as a regional hub.
Also, with NCDs increasing at a fast pace,
especially diabetes, foreign companies can
provide their innovative products knowing
there will be a high demand. Currently, for
the public sector, innovative drugs in terms
of value represent 60 percent and 40 percent
in volume, while generics represent 40 percent in value and 60 percent in volume. This
is encouraging, but we believe there is still
room to grow for innovative drugs.
PB: What can we expect for the development of the Malaysian pharmaceutical and
healthcare sector in the next five years?
What role will PhAMA play?
YEW WEI TARNG: The government is looking at healthcare transformation with many
ambitions. The government through its
National health finance scheme is looking at
how they can better subsidize or bring better
health coverage. We believe the future lies
with universal health coverage and the formulation of one and only healthcare, with the
merger of public and private sector under
one reimbursement system.
From the industry’s side, at PhAMA we are
eager to help companies embrace this transformation and lead them to even more prosperity in a sector which is already experiencing double digit growth year after year. Of
course, we see generic companies at the
moment gaining more momentum than innovative ones, but with the recent EPP implementations, we shall see new opportunities
for innovative companies, especially with
improved market access.
PhAMA is actively engaged in discussions
about NKEA and national health policies.
These include discussions on medicine governance, market access, regulatory approval,
rational drug utilization and industrial partnerships. We hope the government will not
engage in cost containment measures in the
coming years as this will limit the innovative
development of the sector.
We also want to empower consumers and
raise the level of self-medication. This is supported through initiatives from our member
companies.
MALAYSIA JANUARY 2015
22 CSR Initiative
Sanofi’s Dengue Patrol
Launches Nationwide
Initially launched in 2011 as a pilot program, Sanofi’s complications. The severe form of the disease, known
Dengue Patrol program went nationwide across as dengue hemorrhagic fever (DHF), affects around
Malaysia in 2014. The program was developed in a half a million people each year, most of them children,
bid to spread awareness of dengue among younger and is the leading cause of hospitalization from dengenerations. Under the program, students
gue. In countries where healthcare systems
across the country are encouraged to form
are strained, dengue is an enormous burpatrols that then carry out activities to proden, but the WHO aims to reduce dengue
mote dengue prevention, and awareness
mortality by 50 percent and morbidity by
of the Aedes mosquito, in a six-week pro25 percent by 2020.
gram, supervised by a teacher advisor.
Sanofi Pasteur has been working on a
The program consists of six compulsory
dengue vaccine for more than 20 years,
elements that are incorporated by the stuwhich is now the world’s most clinically and
dents into the daily activities, both at
industrially advanced candidate vaccine,
school and at home. These elements range
having gone through Phase I and II studies
from community outreach programs, the
in adults and children in the US, Asia and
creation of a mosquito cartoon series and Leah Goodman
Latin America. With large-scale Phase III
a dance movement. As part of the proclinical studies currently taking place in
gram, each school will receive a USD 286 grant from Latin America.
Sanofi to carry out the activities. A total of seven winLeah Goodman, Sanofi’s managing director for
ners will be chosen at the end of the campaign, with Malaysia, Singapore and Brunei, believes that the Denprizes awarded to all participants of the program.
gue Patrol program will be crucial for Malaysia, even
Deaths from dengue fever nearly tripled in Malay- when the vaccine is released. “Having access to a vacsia in 2014, compared to the same period in 2013: in cine should not make people take less precaution in
just the first eight weeks of the year, hospitals recorded their environment,” she explains, before going on to
13,915 cases and 25 fatalities from the disease. Cur- praise the Malaysian ministries of health and educarently, there is no specific treatment available for den- tion for the work they have done in raising awareness
gue, and remains a health priority in many Latin Amer- of dengue through supporting programs like Dengue
ican and Asian countries, where epidemics occur Patrol. “This program played a significant role with
regularly.
school children located in dengue hot spots, where
The WHO estimates up to 100 million infections we must maintain levels of information and awareper year, and although the number of people infected ness.”
with dengue annually is not fully known, the organiza“Sanofi is very prepared for access to our dengue
tion has set a deadline for estimating the true burden vaccine,” Goodman continues, explaining that the
of dengue by 2015. The reason that cases often slip company has a production strategy in place even
through the net is that dengue is often misdiagnosed: before finishing the Phase III trials. “It is truly amazing
the disease spans a large spectrum of clinical symp- to know that Sanofi has been working on the dengue
toms from mild non-specific illness to life threatening vaccine for the last twenty years,” she concludes.
MALAYSIA JANUARY 2015
Focus on 23
Medical Tourism - Just The
(Flight) Ticket
Between 2009 and 2013, Malaysia has experienced and reaccreditation in 2013,” explains Zambahari.
a 129 percent increase in healthcare travelers, thanks “An increasing number of hospitals are applying for
to a growing awareness of the country as a medical international accreditation with JCI (Joint Commistourism destination. This has not hapsion International),” explains Klaus
pened by accident. “For the past two to
Boehncke, PwC’s eHealth lead for
three years we have been engaged in
Southeast Asia.
branding Malaysia, and showcasing the
The deficit of beds in the governcountry as an alternative for people seekment plan for medical tourism still
ing healthcare outside of their country,”
needs to be addressed, however, either
explains Mary Wong Lai Lin, CEO of the
directly or through some innovative
Malaysia Healthcare Travel Council, the
thinking. “The government is currently
government organization tasked with
giving incentives to hospitals to
boosting the country’s status as a health
upgrade their facilities as well as for
destination. “We organized programs to
investors to build new facilities, but I
bring the awareness of Malaysia to the
strongly believe in the advancement in
Zarif Munir of BCG
world—we organize exhibitions and trade
clinical science in Malaysia as a way to
shows, and we work with different stakeholders in tackle the deficit of beds—we do a lot of minimally
different parts of the world, engaging them and let- invasive procedures and services, which means we
ting them know that Malaysia is a destination. We don’t need long stays in the hospital,” explains Lin
also work with our tourism board here in Malaysia of the MHTC. “Even a heart bypass can be done
and we collaborate to brand Malaysia as a medical within a day and in the next two days the patient can
tourism destination.”
be discharged. So we are not talking about needing
Indeed, the Malaysian government has set targets too many beds to build capacity. We are doing a lot
for medical tourism, as Chua Hong Teck, director of of procedures on a daily basis—eye surgery, spinal
the Healthcare NKEA at Pemandu explains. “The tar- surgery and knee replacement are done in a miniget at hand is to reach one and half million healthcare mally invasive way.”
travelers by 2020, but this means we also need ten
However, there are those that believe that Malaysia
thousand more beds from the private sector. The still has a long way to go to become a long-term value
revenue generated from medical tourism is RM 690 proposition for medical tourists. “Medical tourism is
million (USD 230 million) in 2013 with 770,000 travel- not just about the medical procedure,” opines Zarif
ers and this is about 15 percent growth from previous Munir, partner and managing director of Boston Conyears.”
sulting Malaysia. “It’s about the end-to-end customer
This effort is paying off: Malaysia was recently experience. From the time that you land, through to
ranked as the third best place to go for quality and the time that you leave and get post-operative care,
affordable care. Reasons cited in the survey included everything has to be geared up to enable medical
Malaysia’s cultural diversity, level of English and tourism to flourish. If you go to Thailand, for example,
access to medicine and medical procedures, accord- it feels like a complete solution and customer centricing to Tan Sri Dato’ Seri Dr. Robaayah Zambahari, ity is pivotal to the offering. Today this is only seen in
chief executive director of IJN National Heart Insti- pockets in Malaysia. It is only my opinion, but I think
tute. This has come along with improved standards Malaysia is at a disadvantage: people who can afford
and international accreditation at medical facilities. it prefer to go to Singapore where they can get sophis“IJN has taken great strides in achieving international ticated clinical care, and people who are looking for
accreditation, having been first obtained the Joint an affordable solution and a total experience will go
Commission International JCI accreditation in 2009 to Thailand or India.”
MALAYSIA JANUARY 2015
24 Interview
Beating Heart Disease
in Malaysia
The National Heart Institute’s CEO offers her perspectives on the
impact of the healthcare NKEA on hospitals, and specifically on
the prevention of heart disease in Malaysia
PharmaBoardroom: How would you
define IJN’s role in the context of the
healthcare NKEA implemented in Malaysia in 2011?
TAN SRI DATO SERI: Institut Jantung Negara (IJN) or National Heart Institute is a
stand-alone institute for cardiovascular and
cardiothoracic care, incorporated in September 1992, with the Ministry of Finance
as the principal shareholder.
IJN is a leading provider of comprehensive integrated cardiovascular and thoracic
care services in Malaysia. As the national
referral center for cardiovascular disease,
IJN sees new cases referred from all over
the country as well as follow-up cases at
the outpatient clinics. The center is
equipped with the best in class technologies and is poised to become the market
leader in Asia by offering a comprehensive
range of services for cardiovascular medicine with a wide range of interventions –
medical, interventional and surgical.
PB: What are your thoughts on the positive effects of the healthcare NKEA in
Malaysia since it was introduced?
TAN SRI DATO SERI: The healthcare sector has seen robust growth over the past
decade and this sector has one of the highest multipliers in the economy in Malaysia.
Changing demographics, a more affluent
society and more health-conscious lifestyles have led to the creation of a robust
domestic industry.
While the local industry has been dominated by the public healthcare sector, over
the past decade, there has been tremendous growth of private healthcare services.
As such, the government, through the
healthcare NKEA, aims to further grow this
sector by encouraging more private investments in areas such as manufacturing of
pharmaceutical products, medical devices,
clinical research, aged-care services and
supporting collaborative efforts between
public and private healthcare providers.
PB: What is the institute’s commitment
when it comes to developing clinical trials in Malaysia?
TAN SRI DATO SERI: Research and development are among the ingredients of a
center of excellence. The mechanisms for
research and development to progress are
in place – research committee, research
department with a qualified statistician as
the head and with 11 clinical research assistants and 11 officers handling data management.
In the field of research, we also have
established memorandums of agreement
and understanding with universities including University Kebangsaan Malaysia, University Technology Malaysia and Baker IDI
Heart and Diabetes Institute in Melbourne,
an independent, internationally renowned
medical research facility.
IJN has been involved in numerous multinational multicenter clinical trials, many of
Dr Robaayah Zambahari, TAN SRI DATO SERI, CEO, IJN NATIONAL HEART INSTITUTE
MALAYSIA JANUARY 2015
25
which subsequently were published in established international medical journals and the
outcomes of some of these clinical trials have
impacted our clinical practice and have become
guidelines in our management of patients.
PB: Medical tourism is also on the government’s agenda with great opportunities to
grow considering what Malaysia offers.
What are your views on this phenomenon
and does the Institute have an interest in
specifically attracting international patients?
TAN SRI DATO SERI: Between 2009 and 2013,
Malaysia experienced a 129 percent increase
in healthcare travelers. Malaysia was recently
ranked as the third best place to go in the world
for quality and affordable care. Accessibility,
language proficiency and cultural diversity have
made our country stand out from its regional
peers in the last decade. This, combined with
IJN’s clinical excellence in cardiovascular and
thoracic care, has led us to conclude that medical tourism is an opportunity for us to attract
more international patients.
Playing our role in supporting the government’s initiative towards medical tourism, we
have equipped our facilities and services to
meet the demand and needs of foreign
patients. An international patient center has
been set up in IJN, with the brief of facilitating
the travel and logistics of international patients
and accompanying family members. Here, the
members of the IJN international patient services team provide assistance such as helping
with flight arrangements, arranging for visas
and helping with immigration clearance, coordinating the exchange of information between
the specialists at IJN and the patient’s own doctor in his or her home country, and assisting
with admission and discharge matters such as
bill payment, insurance claims and medical
leave.
PB: What role does IJN play in raising awareness around the prevention of heart disease
in Malaysia?
TAN SRI DATO SERI: As an established leader
in educating the community, we discuss heart
disease awareness and prevention, often with
health screening, at functions like world heart
day, international women’s day, at corporate
organization’s visits to IJN, and also when we
are invited to corporate organizations’ staff
days. We also regularly conduct corporate
social initiative programs in various areas in the
country. During these sessions, there will be
health talks by health professionals on heart
disease and prevention, health screening of
height, body weight, blood pressure, blood
sugar and cholesterol, with the results being
looked over by counselors. Where feasible, we
also demonstrate Cardio Pulmonary Resuscitation (CPR) techniques.
PB: As the founder and charismatic leader
of the National Health Institute of Malaysia,
what would you like to achieve in the coming years for the Institute, for cardiology
worldwide and for the international reputation of Malaysia?
In Malaysia, heart disease is the main cause of
death in Malaysian hospitals, for both men and
women, accounting for approximately 25 percent of total deaths. We have to prevent this
disease. Prevention needs to be done at various levels. From primary prevention for those
not yet afflicted, to the detection and management of risk factors, with healthy lifestyle as the
mainstay of treatment, and medications only if
healthy lifestyle is inadequate in reaching targets. The next level is detection of disease and
management of disease and its consequences.
Again healthy lifestyle is the mainstay of treatment, and, if necessary, medications and intervention (coronary angioplasty or coronary
artery bypass graft surgery). After these procedures and surgery, there remains the need
for prevention of disease progression and
hence, healthy lifestyle remains an important
component of treatment.
TAN SRI DATO SERI: PB: I would like IJN to
continue to grow, in provision of quality
healthcare, in research and education, and
contribute towards a healthier Malaysian
society.
TAN SRI DATO SERI: I would like for Malaysia’s
reputation to grow and be known for its healthy
society and the advanced level of its healthcare.
MALAYSIA JANUARY 2015
26 Interview
Improving Malaysian
Hospitals
The president of International Medical University Malaysia discusses the challenges currently being faced by the country’s hospitals, and what can be done to retain talent in the country being
trained by IMU today.
PharmaBoardroom: What are the
biggest challenges for improving
medical educational standards in
Malaysia today?
TAN SRI DATO DR ABU BAK AR
SULEIMAN: The issue is about how to
develop human capital that is appropriate for the needs of the industry. We
need to get our graduates up to the
standards and requirements of the
industry. This is not, however, peculiar
to Malaysia; many countries around the
world are facing this problem, because
of rapid advances in science and technology: education has to run to catch
up. In Malaysia, the government has
been trying to improve upon this in the
past ten years, however, it’s not been
improving quickly enough for the
needs of the industry. The focus needs
now to be on the quality of education
and the application of knowledge,
rather than on the acquisition of knowledge alone. These are the major issues
where we are trying to make a change.
PB: How many companies are partnering with International Medical
University (IMU) on the healthcare
side at the moment?
TAN SRI DATO DR ABU BAK AR
SULEIMAN: IMU has over 30 partners
internationally. We have a big research
program; however, we are a small university, and we are private. We focus
Tan Sri Dato Dr Abu Bakar Suleiman, PRESIDENT, IMU MALAYSIA
MALAYSIA JANUARY 2015
on research and we also cater to the
needs of the industry.
PB: There is a double brain drain taking place here in Malaysia at the
moment—doctors moving from the
public sector to the private sector,
and healthcare and medical practitioners moving from Malaysia to
other countries, mainly due to higher
salaries in other countries. How do
you think this issue can be con tained?
TAN SRI DATO DR ABU BAK AR
SULEIMAN: We have to try to make
things more attractive so they want to
come here. Half the doctors in Singapore are Malaysian. We send a lot of
our graduates to the US, the UK and
Australia where they get their training
and, subsequently, they get jobs there.
So we have to work harder to make it
attractive here so they want to come
back. Other wise, it’s a waste of our
expertise. We are seeing though, that
as we build more and more new hospitals, they are starting to come back.
Of course, our earning power is low
in Malaysia, which is a problem; but on
the flip side, the cost of living is so
much lower here as well than it is in
Singapore, for example. As the country
develops, more and more of our doctors will come back.
27
PB: Would you agree that Malaysia does
not have enough experienced business
managers and CEOs to lead both local
and multinational companies? Do you
think that Malaysia has enough talent to
cope with current demand?
TAN SRI DATO DR ABU BAKAR SULEIMAN: We are growing too fast and human
capital is a major problem here, which is why
the current focus on education is so high.
We need more capability for learning in this
country—learning on the job, for example.
And likewise, we need to invest more in education.
The other thing that is important when
you want to be a developed country is the
way in which you do things, which must meet
the mentality, philosophy, value system, and
standards of a developed country. In terms
of human capital, we need to train them
up—to be excellent hospital managers, for
example.
We are growing too fast and human
capital is a major problem here, which
is why the current focus on education is
so high. We need more capability for
learning in this country
PB: What is the best healthcare model for
Malaysia, and how do you see this developing in the coming years?
PB: Where do you see the growth of the
healthcare and pharmaceutical industries
in the next three to five years? Is it capable of maintaining a 10 percent growth
rate year-on-year?
TAN SRI DATO DR ABU BAKAR SULEIMAN: It’s going to be tough. For Malaysia
the priority should be to focus on manufacturing value added products, and we must
also focus on being early into certain fields
like biologics, for example. A country will
not become developed and advanced if it
focuses on low cost manufacturing and basic
healthcare. We need to take Malaysia to the
next level and the government will play a
big role in this journey to excellence.
TAN SRI DATO DR ABU BAKAR SULEIMAN: The Philippines’ healthcare system is
a good example for us. We want the standards from the west, but we have to do it in
our way; for example, patient safety and
product safety are very important and there
is no compromise in this. But, to achieve this
you have to take into account context—the
training is critical, there’s no way you can
avoid it. But, the software and how we motivate people and build solid relationships
with people has to be local, Malaysian. The
incentives are the same wherever you go,
but putting it into a local context is very
important.
industry, there are a lot of questions to
address, and these trade agreements won’t
be sufficient alone to develop exports for
these companies. When talking about pharmaceuticals and medical devices, our companies certainly are very competitive, but
the government must also allow us to be
competitive. We have witnessed many government practices which have distorted the
pharmaceutical industry and therefore it is
necessary for the government to be closer
to the industry and understand how collaboration can be beneficial for both sides.
PB: We have seen the rise of exports,
which will only increase with the Transpacific Agreement and Asian harmonization.
What is your perspective on these trade
agreements?
TAN SRI DATO DR ABU BAKAR SULEIMAN: In terms of the local pharmaceutical
MALAYSIA JANUARY 2015
28 Company profile
Pharma’s Role in a Diverse Portfolio
Launch of Insugen. Photo Credit: CCM
2013 was not an easy year for CCM Group, with poor
market conditions affecting the performance of the
group’s chemical and fertilizer divisions. However, its
third main division, pharmaceuticals, delivered strong
results, with before tax profit increasing by 34 percent to RM 34.1 million (USD 9.49 million) on the back
of higher revenues of RM 295.9 million (USD 82.32
million), a four percent increase from 2012. The
pharma division saw increased sales in both the public and private sectors domestically, while also
increasing export sales.
MALAYSIA JANUARY 2015
On the R&D side, CCM has one product currently
in clinical development, an erythropoietin (EPO) biosimilar developed for use in the treatment of anemia
in end-stage kidney failure patients, in collaboration
with PanGen of South Korea: clinical trials have
already commenced in both South Korea and Malaysia. The development of this drug is part of the company’s strategy to
Commercialize biotherapeutics while eliminating
the need to invest in very expensive clinical trials and
long gestation periods to deliver them to the market.
The partnership with PanGen was strengthened
further with the conclusion of a purchase of a 13.86
percent equity stake in the company by CCM in
December 2013. The equity stake is reciprocated
through exclusive marketing and commercialization
rights in Malaysia, Singapore and Brunei, granted to
CCM for all biotherapeutics developed by PanGen.
In this regard, CCM’s equity stake in PanGen allows
its pharmaceuticals division to have strategic access
to a biotherapy product pipeline as there are very
few start-up biotherapy companies globally with the
expertise, track record and range of cell lines already
developed by PanGen.
In addition to its partnership with Pangen, CCM
29
is also collaborating with India’s Biocon to market its
range of human insulin products in Malaysia, supplementing the portfolio of biotherapeutics being
developed by CCM.
Through its product pipeline strategy initiative,
launched in 2012, CCM’s pharma division continued
to launch new products throughout 2013 such as
Dermoplex Simple Cream (for skin relief), Acetan
HCT 50mg & 100mg (for high blood pressure), Dexproco Syrup (for cough and cold), CCM Cyanocobalamine (Vitamin B12 injection) and Duopidogrel
(anti-thrombotic agent).
Internationally, CCM has been expanding its presence in regional markets, with Singapore and the
Philippines showing strong growth and profitability
in recent months.
Halal has also become a key area of interest and
potential growth for the company, with the company
obtaining the first halal pharmaceutical standard in
2013. As demand for halal products continues to
grow in Malaysia, CCM is well positioned to capitalize.
In 2013, Frost & Sullivan named CCM’s pharmaceutical division the generic pharma company of the
year at its annual Malaysia Excellence Awards. In
2014, CCM’s pharma division had planned to have a
successful year on both commercial and operational
fronts. Commercially, 2014’s objective was to improve
domestic market penetration initiatives, launching
of new products and a continued push in export
markets. Operationally, in 2014 CCM aimed to focus
on supply chain to support a continuing growing
business, looking at long-term storage capacity and
depot management. With a continued focus in biotherapeutics, niche therapeutic areas, revitalization
of OTC range, regional expansion and Halal leadership in the pharmaceutical space.
MALAYSIA JANUARY 2015
30 Interview
The Future of Malaysian
Clinical Research
The managing director of Info Kinetics remains optimistic about
the future of clinical research in Malaysia and expects the country
to come a true hub for Phase I by 2020 with the help of entrepreneurially-minded scientists.
PharmaBoardroom: What are, in your
opinion, the key aspects of clinical
research that Malaysia should be
looking to improve?
Toong-Chow Lee: Phase I trials are definitely an area where Malaysia stands
behind compared to other countries in
Asia Pacific. In fact, Info Kinetics is the
only organization pursuing a specialization in Phase I research. The government is not actively marketing Phase I
trials and this results in a lot of skepticism amongst Malaysians to participate.
However, this is definitely a matter of
time and nothing that cannot be solved
with more exposure and publicity.
set guidelines. We have not yet
achieved 100 percent of our initial
goal. However, I would say we are
now at 70 percent. It is my personal
belief that it is relatively easy to reach
50 percent of an objective. What
requires the most effort is reaching
90 percent, and to do this, the manner in which the development is managed is what is important. Having
worked in this industry for 23 years, I
am very optimistic about the future
and I predict it will take us another
five years to reach 90 percent of our
goals.
PB: Have you experienced any tangible development brought by the
healthcare NKEA and how far do you
believe Malaysia has progressed until
now?
Toong-Chow Lee: I am very pleased
with the support the government has
been giving and the generous funds
they allocated towards regulations, as
this will increase our exposure overseas. The government is open to discuss changes in current policies and
PB: How important is it for Info Kinetics to partner up with other CROs and
what do you hope for the company in
the future?
Toong-Chow Lee: Malaysia has been
moving into two sectors: CRO (clinical
research organization) and SMO (site
management organization). Info Kinetics is a CRO specialized in Phase I. However, as the overall margins that CROs
can make will drop, we hope to be more
than that in the future. Organizations
I am very pleased with the support the government
has been giving and the generous funds they
allocated towards regulations, as this will increase
our exposure overseas.
Toong-Chow Lee, MANAGING DIRECTOR, INFO KINETICS
MALAYSIA JANUARY 2015
31
such as Quintile have decided to localize
their costs to the Malaysian market and I
believe this is the reason why they have
been so successful. Other companies are
still using international prices, which might
be making them uncompetitive. Eventually,
I hope for Info Kinetics to become part of
a conglomerate or an alliance of international importance. What is most important
for the future of the industry is know-how
and this is something we definitely have
here. We do not have a marketing team and
we rely a lot on word of mouth but I would
definitely appreciate working closely with
more CROs and SMOs in the future.
PB: How long do you think it will take for
Malaysia to become a hub for early stage
trials?
Toong-Chow Lee: Malaysia can already
be considered a hub for Phase III trials.
The difficulty lies in people’s mindsets. I
once told the Minister of Health that if I
were the CEO of a government CRC (clinical research center), I could increase
their revenue by 100 times! Being in this
hospital gives us a close reach to patients
and therefore I have changed our strategy towards Phase II as our expertise in
Phase I will be a great advantage. Personally, I believe our forte will be Phase I and
Phase II. Phase II will be possible for
Malaysia to take up, but becoming a
Phase I hub will not be easy. We would
need a lot more understanding in terms
of side effects but it would also require
a lot of government support which I am
not sure would be the case. Malaysia
needs scientists with entrepreneurial
spirit to become a hub for Phase I, and
such individuals are not easy to find here
at the moment. I do believe the government has done a lot to help and I genuinely think they understand the situation
but one thing that can definitely be
improved is the link between the private
sector and government services.
Malaysia needs scientists with
entrepreneurial spirit to become a hub
for Phase I, and such individuals are not
easy to find here at the moment. I do
believe the government has done a lot
to help and I genuinely think they
understand the situation but one thing
that can definitely be improved is the
link between the private sector and
government services.
PB: Info Kinetics is the leading organization for Phase I trials and recently managed to partner up with great hospitals
like Gleneagles. How have these recent
successes financially manifested in the past
three years?
Toong-Chow Lee: We are a company that
always sets long-term goals. We are not a
listed company that only looks at the bottom line. Our profits actually benefit our
hosting hospital: 50 percent of our budgets
go to the hospital and this helps to maintain a great relationship with Gleneagles.
Looking at what makes us most welcome,
first of all, we introduce new techniques
that are necessary in research but are not
usually part of the hospital’s general routine, so they appreciate our knowledge and
give us great support. Financially, we are
growing at a rate of 30 percent. However,
in my view, this is still not good enough.
Our team is composed predominantly of
scientists and I am sure that if we had more
business-minded people like at Quintiles,
we would be growing at a much faster rate.
MALAYSIA JANUARY 2015
32 Interview
22 Trials & Counting
“Clinical trials are an area where we want to build capabilities,
both internally and externally,” says Novartis’ Corporation Malaysia President and Managing Director. Novartis with 22 ongoing
trials is one of the leaders in Malaysia and clearly understands the
benefits as the government is promoting trials through the healthcare NKEA.
PharmaBoardroom: Among the efforts
that have been implemented by the
government recently, especially with
the healthcare NKEA program, how is
Novartis performing on the clinical trial
side?
MICHAELA DINBOECK: The government has done a great job at raising the
profile of Malaysia as a destination for
good clinical trials. Since Novartis is an
innovation driven company and we hold
one of the richest pipelines in the industry covering a wide range of diseases, it
has been mutually beneficial to perform
clinical trials locally. Clinical trials are an
area where we want to build capabilities
both internally and externally. Therefore
we have run training workshops with over
a hundred scientists and experts on how
to establish strong scientific hypotheses
or write applications. All of these workshops have the aim to reinforce the local
capabilities which then allows us to run
good clinical trials.
We are currently running 22 clinical
trials in Malaysia with 900 patients
involved and we are developing various
feasibility studies to bring in more trials.
Malaysia therefore represents an important trial site for the group. English is
well spoken and the government supports the industry and intervenes if we
are facing issues. This is not the case in
many countries. Finally, Malaysia has an
increasing number of institutions capa-
ble of running high quality studies,
which is fundamental for us.
The trials we conduct are part of
global multicenter studies, which
means they fulfill the highest criteria
and standards in terms of data, processes, safety and results. We are conducting trials locally in heart failure,
oncology and ophthalmology.
PB: Could you take us through the
industry’s market access challenges,
and the necessary steps needed before
getting your products registered on
the “blue book”?
MICHAELA DINBOECK: The regulatory
process in Malaysia is relatively straightforward; with a timeline of 12 to 15
months for non-high risk disease areas or
six to nine months with fast track regulatory approval for high demand and crucial medicines targeting the most important diseases. Once this regulatory
approval is fulfilled, it is possible to
launch our products on the private market - The public sector requires getting
listing in the blue book. From an industry
perspective it is an advantage to be able
to directly launch products on the private
sector, while getting listed for the public
sector.
To access the blue book you need
to go through many different steps. The
first step is that you need to have a base
of doctors who would be willing and
Michaela Dinboeck, PRESIDENT AND MANAGING DIRECTOR, NOVARTIS MALAYSIA
MALAYSIA JANUARY 2015
33
Our biggest challenge is
retention of talent as there is
virtually no unemployment.
Therefore we see that many
companies are competing
for the right talent, making
retention even more
challenging.
interested to use your product. Once they
find this product to be of value, there are
a series of administrative processes. Once
these are fulfilled, you get listed in the blue
book. Listing in the blue book is not a guarantee for funds. Registration is a straight
forward process, whereas government
reimbursement for broad patient access to
certain drugs still requires multiple steps
and effort. So far, we have blue book listings in diabetes, hypertension, ophthalmology, neurology and oncology.
PB: What do you see as the main challenges faced by Novartis in Malaysia?
MICHAELA DINBOECK: Managing the
uncertainty around the implementation of
the “One Care” program as well as the GST
(Goods and Services Taxes) represent a challenge. Both will demand very different strategies and so far it is impossible to know what
will be the best way to address these two
issues.
doing as well, we decided it would be
mutually beneficial to work hand in hand
on these matters to take them to the next
level. In this sense, the MoU was very positive.
PB: Building the right team is one of the
key success factors for any pharma CEO
anywhere in the world. In an emerging
market, finding human capital may be even
more challenging. What are your observations of the situation in Malaysia?
MICHAELA DINBOECK: Our biggest challenge is retention of talent as there is virtually no unemployment. Therefore we see
that many companies are competing for the
right talent, making retention even more
challenging.
Novartis has implemented various human
resources programs beyond the usual talent
mapping and development planning to help
develop new capabilities and to keep associates motivated. One of the most interesting ones is our program called “Be Healthy”.
Be Healthy is a health and well-being initiative that encourages our associates to live
healthier lives As part of a global initiative,
Novartis participates in a corporate challenge, where every affiliate and participant
competes on who is walking the most number of steps. Many of our employees have
decided for instance to use the stairway
instead of the elevator, and have moved
from the average 10,000 steps per day to
as high as 29,000 steps a day.
Two years ago, Novartis Malaysia began
a memorandum of understanding with the
ministry of health. Could you tell us about
your special collaboration with the government?
Our collaboration with the government
would have taken place with or without a
MoU. But because we identified various
areas where the government was focusing,
such as clinical trials, capability building
and access to medicine which we were
MALAYSIA JANUARY 2015
34
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35
Company index
BCG 8, 23
*CCM Frost & Sullivan 10, 13, 28, 29
10, 12, 29 *GCI 14
GSK 18 *Healwell 14
IJN National Heart Institute INC Research *Info Kinetics International Medical University Kotra Pharma Malaysian Investment Development Authority Malaysia Healthcare Travel Council Ministry of Health 7, 9, 23, 24, 25 10, 12
12, 30, 31
12
8 8, 9, 18, 19 23
4, 5, 8, 9, 10, 16 , 19, 21, 22, 24, 33
*Nashmir Capsule 13
Novartis 18, 32, 33
PEMANDU 10, 13, 23
PhAMA 7, 8, 9, 20, 21
*Sanofi 8, 9, 10, 13, 22
*Servier 4, 8
* Advertiser
MALAYSIA JANUARY 2015
36
MALAYSIA JANUARY 2015