D517A Thailand Biotech Guide 2006-2007

T H A I L A N D B I O T E C H G U I D E 2 0 0 6 / 2 0 0 7 8
hai l and has l ong real i zed t he

importance of biotechnology and the
tremendous benefits of having a
strong biotechnology sector. Given its position
as a world leader in tropical medicine, health
services, agriculture and food production,
Thailand recognizes that the biotechnology
industry will help strengthen the countrys
capabilities in these areas and contribute to
future growth and competitiveness.
Since the early 80s, Thailand had already taken
steps to encourage and nurture a fledgling
biotechnology industry. Early initiatives such as
the establishment of the National Center for
Genetic Engineering and Biotechnology (BIOTEC)
provided the necessary impetus and laid a strong
foundation for biotechnology human resource
development and R&D activities. Setting up of
the National Science and Technology Development
Agency (NSTDA) in 1991 reaffirmed the
belief in building S&T infrastructure to build
competitiveness and upgrading S&T capacity. In
addition, with the approval of the National
Biotechnology Policy Framework by the Thai
Cabinet in 2004, the industry can now work
towards a clear set of goals, namely in using
biotechnology to promote the development of
new bio-businesses, enhance the competitiveness
of the Thai food and agriculture industries, raise
the level of medical healthcare services in the
kingdom, conserve the environment and
produce clean energy, create a self-sufficient
economy and develop qualified human resource.
As a result, the local biotechnology industry has
grown. Thailand has already attracted a number
of multinational corporations to base their R&D
activities here. It is also home to a rapidly
growing international medical tourism industry
whose world-class hospitals and medical
professionals are bringing in more than a
million visitors a year from around the world.
Biotechnology is todays frontier of Science and
BIOTEC, which has since become a part of NSTDA,
has used various NSTDAs instruments in playing
a key role of creating a conducive research
environment, a critical pool of talents and
effective infrastructure and tools that will enable
biotechnology to benefit the country and the
well being of the people. Furthermore, we are
continually strengthening the industry by bringing
together multiple disciplines, synergizing with
key partners and promoting both local and
international collaborations.
Market-driven initiatives such as the Thailand
Biotech Guide which showcases the local industry
and provides access to important market
information, is evident of an industry that is
moving to the next level of development. I hope
the readers will gain insights into Thailands
biotechnology industry and come to appreciate
the many prospects and opportunities that
are abound here.
Sakarindr Bhumiratana, Ph.D.
President
National Science and Technology
Development Agency (NSTDA)
T
Message biotech 6/10/06, 10:35 8
ver the years, with sustained
commitment from the government
and concerted efforts from the
relevant agencies, Thailand has focused on
developing a biotechnology base that will
bring its agriculture-dominant economy to
the next level.
Agencies such as BIOTEC, NSTDA and the
BOI have worked closely together to promote
the long-term growth and development of
Thailand's biotechnology sector. Through their
efforts, the creation of biotechnology
incentives, funding and other forms of
support were undertaken specifically to
provide an environment conducive for growth
in this important sector. And now we are
starting to see the emergence of a promising
industry that currently boasts a small but
increasing number of biotechnology companies.
The creation of the Thailand Biotech Guide
by an industry-driven consortium is another
indication that the sector has reached an
important milestone. The demand for key
industry information has now reached
critical mass.
I am confident that this new publication,
the Thailand Biotech Guide will become an
invaluable resource for the local biotechnology
industry, as well as foreign companies and
investors. My best wishes to the publishers,
and I look forward to seeing this publication
grow as Thailand's biotechnology industry
powers forward into the future.
Satit Chanjavanakul
Secretary General Board of Investment
O
Message biotech 6/10/06, 10:36 9
ince adopting the National Biotechnology Policy Framework in 2004, Thailand has made significant
progress in developing the necessary infrastructure and nurturing specific sectors in its growing biotech
industry. There has been increasing interest in the local biotech industry especially from potential foreign
investors that are keen to learn about the countrys focus and strengths in the biotech field.
The Thailand Biotech Guide is created to provide comprehensive coverage of the operational details related to the
establishment of a local biotech operation and enterprise. Our aim is to develop a publication that presents
relevant and practical information to all potential stakeholders and contributors to the Thailand biotech scene. We
envisage that the guide will become an important source of reference for the local biotech industry and will help
promote Thailands biotech sector to the world.
We will like to take this opportunity to thank our advertisers for their support, without which this guide will not
have been possible. We hope that you will find this guide useful and we look forward to your comments and
feedback to help us improve this publication further. Please feel free to drop us an email at
feedback@biotechthailand.com.
Co-Editors
S
Derrick Tan, Ph.D.
Managing Consultant
1st Phase Operations
Marvin Ng, MBA
Business Development Consultant
Greener Grass Communications
Editorial preface 6/10/06, 10:42 11
Thailand Land of
Investment Opportunities
Thailand is a key economy in South East Asia, with an
estimated population of 66 million and a gross domestic
product (GDP) of over 7,100 billion baht or US$ 186
billion in 2005. Having weathered the Asian financial crisis
in 1997, Thailand has undergone a remarkable economic
transformation which propelled the economy from about
minus 10% growth to almost 7% growth in 2003.
Although economic performance has slowed down in 2004
and 2005 due in part to rising oil prices, the 2004 tsunami
and the outbreak of avian flu, the economy has remained
robust, with 2005 GDP growing at 4.7%.
In 2005, Thailand was rated the third most attractive FDI
destination in Asia (behind India and China) by a UNCTAD
survey. The kingdom is host to a growing number of
MNCs operating out of Asia for a few reasons. Firstly,
Thailand has a sizeable and growing economy with a
substantial domestic market that represents significant
opportunities for companies interested in tapping into local
demands. Secondly, Thailand is committed to creating a
business-friendly and low-cost operating environment that
is conducive to foreign companies. Other key factors
contributing to Thailand's attractiveness as a preferred
investment destination include its young and educated
workforce, its geographical location and its excellent logistic
infrastructure.
Thailand has already established itself as a global base for
a number of industries such as the automotive, electronic
and education sectors. For instance, world-class automotive
players such as Honda and Toyota both have significant
manufacturing and R&D operations in Thailand that cater to
the global market. Similarly, Thailand is also the world's
largest hard disk drive producer with most of the leading
hard disk drive players such as Seagate, Western Digital
and Fujitsu, tapping on the unique strengths of Thailand
and investing in major manufacturing and development
operations in the country. In the same way, biotechnology
companies are discovering Thailand as a promising
investment destination. The country, which is a hot spot in
bio-diversity, has a large domestic and regional market, as
well as a ready supply of competent scientific workers and
scientists. Furthermore, it has developed dedicated
infrastructure and has put in place, attractive schemes and
incentives to support the industry.
The Thailand BioIndustry An Up and
Coming Sector
Thailand regards biotechnology as an important industry
sector that needs to be developed in order to strengthen its
global competitiveness. The Thai government has
recognized the tremendous value of biotechnology in
enhancing economic productivity, especially in the agriculture
and food sectors which are mainstays of the Thai economy.
In particular, there is strong interest to use biotechnology
for a variety of activities including processing food,
Editorial biotech 1 6/10/06, 10:57 15
increasing value-add of products, improving the genetic
stock of plants and livestock, developing diagnostics,
enhancing aquaculture and developing biological control.
As early as the 1980s, initiatives such as the creation of the
National Center for Genetic Engineering and Biotechnology
(BIOTEC) were launched to promote the development of
the local industry. More recently, the Thai government
developed the National Biotechnology Policy Framework
(2004-2009), which aims to bring about US$125 million in
R&D investments and the creation of more than 100 new
biotech-related companies in the next few years. To meet
these objectives, the government has provided significant
resources to create an environment conducive for the growth
of biotechnology industry including setting up a dedicated
BioPark for R&D, creating training and business activities
as well as establishing incentives and assistance programmes
aimed at promoting the industry.
Key clusters within the bioindustry in Thailand include the
Agri-biotech sector, the Medical sector and the Food sector.

Agri-Biotech Sector
Thailand is a major agriculture exporter, with more than a
third of its land being arable and about half of the country's
labour force involved in agriculture. In 2005, the country's
agriculture output contributes 8.7% to its GDP. Thus, the
Thai government has long realized that biotechnology,
applied to the country's agriculture base, can bring
tremendous benefits to the economy and people.
With a large industrial base, in-depth experience and expertise
in this area, Thailand possesses significant strengths in
biotechnology within the agricultural sector and is already
home to a number of international companies such as Bayer
Cropscience, Monsanto and Syngenta. The country is now
leveraging upon biotechnology advances to further develop
the field and grow the industry. For example, marker assisted
selective breeding has been used to develop disease resistant
crops such as rice. Similarly, recombinant DNA techniques
are used to produce more hardy transgenic plants including
tomato, papaya and pepper. Biotechnology is also finding its
way into other areas such disease (livestock and crops)
diagnostics and agricultural product traceability.
Within the same sector, biotechnology is playing an
increasingly important role in the production of biofuels and
materials from agricultural biomass. One specific example
is the government's active support for projects related to
the production of bioethanol from cassava, sugar cane and
other agricultural materials, in an effort to augment the
country's energy needs.
In the area of human resource development for the
agri-biotech sector, Thailand is not only focusing on its
own needs but also those of the region. It is establishing
itself as a regional hub for training and development. For
instance, the Asian Development Bank has sponsored
training initiatives that are based in Thailand which reach
out to participants from neighbouring countries. This aims
to strengthen the agriculture capacity and advanced
agricultural science and technology cooperation among
nations in the region.

Medical Sector
Thailand is poised to become the region's leading healthcare
hub with over a million medical tourists arriving each year
seeking treatments including cosmetic surgery, dental work,
hip and knee replacements and back surgery. Thai doctors
and other medical staff study abroad, speak international
languages and are among the best qualified in the region.
Many private hospitals have translators to facilitate
convenient communication with foreign visitors. The hospital
facilities themselves offer spacious, luxurious accommodation
and in some ways seem more like five-star hotels, with in-house
restaurants and food courts, spa and fitness facilities. Tourists
from the United States, Europe and increasingly the Middle
East are attracted to Thailand specifically because of its
high-quality, attractively packaged and very affordable medical
treatments. Furthermore, Thailand also offers medical
treatments that are sometimes unavailable to these medical
tourists back in their home countries, for example stem
cell therapies. In 2005 alone, medical tourism brought in
more than half a billion dollars for the Thai economy.
With its superb medical healthcare infrastructure, well-trained
medical personnel and a growing research base, the sector
is poised to become a major clinical development center in
the region. Thailand has established a number of initiatives
to make this happen. For example, it has undertaken the
Thai Pharmacogenomics Project with the aim of creating a
comprehensive clinical database that will ultimately facilitate
new drug discovery efforts with leading pharmaceutical
companies and reduce healthcare costs.
Thailand is also at the forefront in the application of stem
cell technology. There are already organizations in the
country that offers commercial applications such as cord
blood banking and stem cell therapies.

Food Sector
Thai food industry is the most dynamic and diverse in the
world. The sector contributes significantly to the country's
growth and prosperity. More than 11.72% of the country's
total exports originate from the food sector, and the industry,
together with the agriculture sector, employs almost 20
million people in 2003. There are about 10,000 food-related
manufacturing operations in Thailand and 80% of the raw
materials that go into production are harvested locally. Given
the importance of the sector, it is not surprising that the
industry is continuously looking to improve itself. This
presents further opportunities for companies to improve upon
existing production or add value to existing products through
the use of technologies including biotechnology.
In general, the sector is moving towards higher
value-added, functional foods and nutraceuticals. It is also
developing a more robust value chain that incorporates
higher standards, better safety and strong regulations. For
instance, Thailand's shrimp industry has managed to raise
its productivity and stay ahead of other food exporting
countries through the effective deployment of biotechnology.
The industry has benefited from initiatives such as the
Shrimp Genome Project and the Shrimp Traceability Project
which have helped to improve the shrimp breeding and
cultivation as well as raise the quality and safety standards
of the industry respectively.
More details on opportunities in Thailand biotechnology
industry can be found online at the BIOTEC website at
h t t p : / / www. b i o t e c . o r . t h / b i o t e c h n o l o g y - e n /
newsdetail.asp?id=1420.
The National Biotechnology
Policy Framework Providing
Clear Directions
The National Biotechnology Policy Framework was formally
established in 2003 with the aim of developing a
competitive and self-sufficient Thai biotechnology industry.
restaurants and food courts, spa and fitness facilities. Tourists
from the United States, Europe and increasingly the Middle
East are attracted to Thailand specifically because of its
high-quality, attractively packaged and very affordable medical
treatments. Furthermore, Thailand also offers medical
treatments that are sometimes unavailable to these medical
tourists back in their home countries, for example stem
cell therapies. In 2005 alone, medical tourism brought in
more than half a billion dollars for the Thai economy.
With its superb medical healthcare infrastructure, well-trained
medical personnel and a growing research base, the sector
is poised to become a major clinical development center in
the region. Thailand has established a number of initiatives
to make this happen. For example, it has undertaken the
Thai Pharmacogenomics Project with the aim of creating a
comprehensive clinical database that will ultimately facilitate
new drug discovery efforts with leading pharmaceutical
companies and reduce healthcare costs.
Thailand is also at the forefront in the application of stem
cell technology. There are already organizations in the
country that offers commercial applications such as cord
blood banking and stem cell therapies.

Food Sector
Thai food industry is the most dynamic and diverse in the
world. The sector contributes significantly to the country's
growth and prosperity. More than 11.72% of the country's
total exports originate from the food sector, and the industry,
together with the agriculture sector, employs almost 20
million people in 2003. There are about 10,000 food-related
manufacturing operations in Thailand and 80% of the raw
materials that go into production are harvested locally. Given
the importance of the sector, it is not surprising that the
industry is continuously looking to improve itself. This
presents further opportunities for companies to improve upon
existing production or add value to existing products through
the use of technologies including biotechnology.
In general, the sector is moving towards higher
value-added, functional foods and nutraceuticals. It is also
developing a more robust value chain that incorporates
higher standards, better safety and strong regulations. For
instance, Thailand's shrimp industry has managed to raise
its productivity and stay ahead of other food exporting
countries through the effective deployment of biotechnology.
The industry has benefited from initiatives such as the
Shrimp Genome Project and the Shrimp Traceability Project
which have helped to improve the shrimp breeding and
cultivation as well as raise the quality and safety standards
of the industry respectively.
More details on opportunities in Thailand biotechnology
industry can be found online at the BIOTEC website at
h t t p : / / www. b i o t e c . o r . t h / b i o t e c h n o l o g y - e n /
newsdetail.asp?id=1420.
The National Biotechnology
Policy Framework Providing
Clear Directions
The National Biotechnology Policy Framework was formally
established in 2003 with the aim of developing a
competitive and self-sufficient Thai biotechnology industry.
Editorial Page 17 6/10/06, 14:57 17
The framework provides direction over a period of 6 years
(2004-2009), with 6 specific goals for the development of
the industry as follows:

Emergence and Development of New Bio-Business
To encourage investment in R&D and establish biotechnology
companies which can tap on new opportunities in both
high value-added manufacturing (e.g. production of medical
diagnostic kits and supplementary food) and services
(e.g. molecular-level detection and analysis for medical care,
public health, agriculture and biosafety).

Biotechnology Promotes Thailand as Kitchen of
the World -
To use biotechnology to enhance Thailand's competitiveness
in the agriculture and food industries. The goal is to
increase the export value of the country's raw and
processed agricultural products.

Thailand Represents Healthy Community and
Healthcare Center of Asia -
To utilize biotechnology to improve the medical healthcare
of the nation and to establish Thailand as a lead hub for
healthcare services in Asia.

Utilization of Biotechnology to Conserve the
Environment and to Produce Clean Energy -
To apply biotechnology to the conservation and management
of the environment including energy production from waste,
improvement of soil quality, recycling as well as the inspection,
surveillance, treatment and rehabilitation of the environment.

Biotechnology as the Key Factor for Self-Sufficient
Economy -
To conserve and optimize the use of biological resources
that are important to, or specific in, various local communities.
The goal is to use biotechnology to extend the usefulness
of traditional know-how, expand the diversity and value of
local resources and resource-based products and to improve
the quality of these products.

Development of Qualified Human Resource -
To put in place infrastructure, resources and manpower
development programmes to create a quality workforce that
will support the growth of the industry.
More details on the NBPF can be found online at BIOTEC
website at http://www.biotec.or.th/biotechnology-en/policy.asp.
Strong Infrastructure to Support the
Developing Industry
To support the development of the biotechnology industry,
Thailand has been putting in place critical infrastructure
necessary for industrial growth. The following section
describes some of these in detail.

The Thailand Science Park
Located at the northern outskirt of Bangkok, the Thailand
Science Park represents the nation's first key infrastructure
development to promote its science and technology
research and development. The 80 acre park was completed
in 2002 and is currently managed by the team from the
Technology Management Center under the purview of the
National Science and Technology Development Agency
(NSTDA). The Park is currently undergoing Phase 2
expansion, while planning for Phase 3 development is
already in progress.
The Park aims to be a fully integrated R&D hub to promote
the translation of innovative public R&D to the private sector,
as well as to provide training to advance the country's
critical mass of R&D professionals. To show its resolve to
make the Park the focus point of Thailand's science and
technology activities, NSTDA houses its central administration
and various centers of excellence here. These include:
National Center for Genetic Engineering and
Biotechnology (BIOTEC),
National Electronics and Computer Technology
Center (NECTEC),
National Metal and Materials Technology Center
(MTEC), and
National Nanotechnology Center (NANOTEC)
In addition to these national centers, the Park provides
ready built research, pilot plant and business incubation
space for rental and long-term leasehold lands for companies
to construct their own research facilities. The Park management
also provides its tenants with one-stop services in the areas
of technology and technical, financial, human resource,
business and juristic support. Other benefits include access
to government research grants, soft loans, joint investment
by NSTDA and eligibility for Thailand Board of Investment's
tax incentives (BOI Zone 3 incentives).
In the area of biotechnology, the abundance of state-of-the-
art research activities in agriculture, food and medical biotech
R&D have drawn an increasing number of companies to
set up shop within the Park. The Park currently houses
over 50 private companies, of which one third are active in
biotechnology. Some of the notable companies include
TV SD PSB (Thailand) Ltd., Betagro Group and the Shrimp
Biotechnology Business Unit. Over the years, there is also a
growing culture of scientific collaboration among BIOTEC,
the universities in the vicinity and private companies
located within the Park. BIOTEC also provides access to its
many core resources to private tenants at the Park, such as
the BioService Unit and DNA Technology Laboratory. An
ecosystem of biotech activities is taking shape at the
Thailand Science Park. More information about the Thailand
Science Park may be found at www.sciencepark.or.th.
With an aim of further developing the biotechnology sector,
the National Biotechnology Policy Committee recently
approved the expansion of the current biotech cluster
infrastructure at the Thailand Science Park into a full-fledged
BioPark. A sum of US$16.5 million has been allocated to
create an additional 40,000 sqm biotechnology lab space
by 2009, some of which will be BSL-3 level bio-containment
facilities for use by private companies and public institutions.
When completed, the BioPark will be Thailand's first biotech
hub to promote the advancement of life sciences research
and new bio-businesses.

The Industrial Estate Authority of Thailand
Established in 1972, the Industrial Estate Authority of
Thailand (IEAT) under the Ministry of Industry is tasked to
oversee the country's industrial development policies. In
addition, the state enterprise implements guidelines and
control measures to protect the country's environment against
harmful industrial pollution.
IEAT has developed more than 30 Industrial Estates across
the country, either on its own or jointly with private
developers. These estates are generally equipped with many
of the essential infrastructure needed for a successful
industrial operation. As such, many biotech companies have
chosen to locate themselves within such estates to enjoy
the many privileges and incentives offered by IEAT. For
example, the agency provides a one-stop service to grant
licenses and permits necessary for operation initiation. It
also allows foreign investors to purchase the land they
occupy within certain estates. Additional information on the
various IEAT Industrial Estates and the privilege schemes
available may be found at www.ieat.go.th.
Other than these industrial estates, private developers also
offer ready spaces or leasehold lands at various Industrial
Parks to potential investors. However, tenants in such
Industrial Parks are not eligible for IEAT incentives. In addition,
they do not have access to IEAT's business licenses and
permits facilitation services.

Investment Zones
Thailand's Board of Investment (BOI), through the
enactment of the Investment Promotion Act, divides the
country into several economic zones based on the regions
infrastructure availability and the local citizens income
levels. These zones serve as a guide for the agency to
direct different investment opportunities to the various
regions and to provide added incentives to promote
investment into the lesser developed provinces.
Different tax and duty incentives and privileges are offered
by BOI at each of the zone. Details on these incentives may
be found at the BOI website at www.boi.go.th/english/about/
boi_privileges_by_location.asp.
Public R&D Focusing on Thailand's
Strengths
Much of the biotechnology R&D activities in Thailand are
concentrated in public research institutes and university
research centers. These organizations conduct a range of
research from publ i cl y-funded upstream R&D to
commercially-driven collaborations with companies. With
Thailand's long history and experience in agriculture, aquaculture
and food production, strong biotechnology expertise can be
found in areas including tropical disease, immunology, food
science and technology, fermentation and certain areas of
plant biotechnology. Furthermore, given the country's rich
biodiversity, Thailand has established large germbanks and
natural products libraries for use in agriculture research
and screening for bioactive compounds.
One of the leading biotechnology research institutes in
Thailand is the BIOTEC Central Research Unit, which was
established in 1996. It is the largest in-house research unit
under BIOTEC and NSTDA and conducts basic and applied
research as well as provides technical services to the industry.
Private R&D Activities Commercially
Driven and Close to Market
Although biotechnology R&D activities are concentrated mostly
in public institutions, private sector R&D activities are also
growing. Increasingly, companies are working closely with
public R&D institutes and the universities to develop new
products and innovations. Some of the established local
firms in the agriculture and food industries collaborate with
the local institutions in areas such as agricultural
biotechnology. One example is the Betagro Science Center,
initiated and funded by Betagro Group (one of Thailand's
largest agricultural and animal husbandry companies), which
is the nation's latest private advanced agro-based R&D
institute. The institute focuses on food safety - detecting
bacterial, viral or chemical contamination in products; this
includes the detection of emerging animal diseases, such
as the Avian flu.
In addition, Thailand is gradually being considered by global
firms as a base for R&D activities. It has attracted a number
of foreign investors that have established R&D activities and
research collaborations with local R&D organizations. Leading
international companies such as Shiseido and Novartis
currently work closely with NSTDA research centers. For
example, in 2005, Novartis established a three-year
partnership with BIOTEC aimed at developing new
medicines based on natural products found in Thailand.
Human Resource Development A
Critical Component
Thailand recognizes that it must have a good pool of
scientists, doctors and other biotechnology professionals to
support the nation's developing biotechnology industry. At
present, there are a total of 24 public and private
universities that offer a program in biotechnology. Of these,
14 offer the program at post-graduate level i.e. Masters
or PhD.
In addition, there are joint research centers between BIOTEC
and leading local universities that provide research
programs whi ch contri butes to human resource
development. The Center of Excellence for Shrimp
Molecular Biology and Biotechnology at Mahidol University
and the Rice Gene Discovery Research Unit at Kasetsart
University are examples of such successful collaborations.
Besides the universities and joint research centers, a new
breed of problem-based learning institutes have also been
set up. These institutes focus on R&D training that
addresses the specific needs of the private sector. The
Chemical Engineering Practice School (ChEPS) and Food
Engineering Practice School (FEPS) which were developed
in collaboration with King Mongkut's University of Technology
Thonburi (KMUTT), are successful examples which have
produced graduates with skills and knowledge sought after
by the industry.
The BIOTEC and NSTDA has committed to 244 national
and international scholarships/fellowships per year in order
to strengthen and develop capabilities to cope with technology
changes and future manpower demand.
In all, these programs help ensure a steady supply of
quality manpower that will meet the raising demands and
requirements of research institutes and new biotechnology
companies setting up in Thailand.
Thailand is also building up biotechnology research
capacities for the region. In 2001, Thailand, through BIOTEC,
initiated the Human Resource Development Program in
Biotechnology for Neighbouring Countries. The program
which is funded by the ASEAN Foundation and the New
Zealand UNESCO Commission has trained a steady stream
of researchers from ASEAN countries and also provides a
networking platform for ASEAN researchers.
Support Schemes and Government
Incentives Promoting the Industry
There are a variety of assistance schemes and incentives
from government agencies to assist and attract biotechnology
companies to set up presence in Thailand. The BOI is the
main government agency offering privileges and incentives
to investors. Companies that invest in biotechnology or
biotechnology-related businesses in Thailand may receive
tax or non-tax privileges if their projects receive approval
from the BOI. Tax privileges comprise of corporate income
tax exemption for up to 8 years, import duty reductions or
exemptions on machinery and raw materials. Non-tax
privileges include land ownership rights for foreign
investors, permission to bring in foreign experts and
technicians, and rapid processing of visa and work permit
applications. Companies with R&D activities can also apply
for 200% tax credit on R&D activities from the Thai
Revenue Department.
Biotechnology investors may qualify for financial support
packages from several other organizations. For example,
the Technology Management Center (TMC) offers grants
and soft loans for R&D or to upgrade manufacturing
processes for up to 75 percent of the project budget for
technology development projects (not exceeding US$750,000)
at a competitive interest rate. Various other programs are
available from the TMC including the Industrial Technology
Assistance Program (to provide financial support to
companies seeking external experts from Thailand and
overseas) and the Support for Technology Acquisition and
Mastery Program (to facilitate technology transfer).
The National Innovation Agency (NIA) under the Ministry of
Science and Technology can also offer financial support
and technical services for innovators seeking marketing
assistance. NIA can award soft loans of up to US$125,000
for marketing and feasibility studies. In addition, NIA can
also enter into joint ventures (with less than 25% equity)
with companies and other investment organizations if such
arrangement can result in significant innovation.
Moving Forward
Thailand will continue to establish itself as a major
biotechnology player in the region. With a clear focus that
leverages upon the nation's advantages, Thailand will
concentrate its efforts on key areas of biotechnology R&D.
It will also continue to enhance its supporting infrastructure
and boost the quality and quantity of its human resource.
The establishment of the 40,000 sqm BioPark by 2009
which will accommodate Agro-business, life sciences
research, an incubation center and a pilot plant, will
enhance the country's competitiveness in the bioIndustry.
Thailand's new Suvarnabhumi International Airport, which
has the largest terminal building in the world (563,000
sqm) with a capacity to handle 45 million passengers and
3 million tonnes of cargo per year, will enhance the country's
global logistic network. Finally, the setting up of a
regional training center in biotechnology with the support
from UNESCO, FAO and the Rockefeller Foundation will
help develop strong research capabilities in the region to
meet future demand for qualified manpower from industry.
These and various developments are set to make Thailand
a preferred location for foreign Biobusiness in Asia.
Forms of Doing Business
Types of Companies
A Thai or foreigner may engage in business in the form of
a partnership, limited company, a joint venture, a branch of
a foreign corporation, or a representative/regional office.

Partnerships
There are 3 types of partnerships and they differ principally
in the liability attached to each:
An unregistered ordinary partnership has partners who
are all jointly liable, without any limitation on the
partnership's total obligations. This type of partnership
is not a legal entity and is subject to taxation as if it
were an individual.
While there are many advantages to using the ordinary
partnership business organization, its use by foreigners is
limited by the Foreign Business Act (FBA), if it engages in a
business that is restricted under the FBA. An ordinary
partnership owned by Americans may apply for treaty
protection under the Treaty of Amity and Economic Relations.
A registered ordinary partnership is a juridical entity
having a separate and distinct personality from each
of the partners by virtue of its registration with the
Commercial Registrar. It is treated as a corporate
entity for income tax purposes.
Generally, the registered ordinary partnership form of business
organization is not very popular, since it offers little or no apparent
tax advantages and little or no protection against liability.
A limited partnership is a form of registered partnership,
in which there are one or more managing partners who
manage the business and who are personally liable for
the partnership's debts, and one or more partners who
are not normally personally liable for the partnership's
debts, except for their undelivered or withdrawn capital
contributions. The partnership agreement, including the
details of capital contribution, management and objects,
must be filed with the Ministry of Commerce, in the
same manner as a registered ordinary partnership.
Limited partnerships are a popular form of business
organization, since they provide an aspect of limited liability
with fewer formalities than are required of limited companies.

Private Limited Companies
The private company is the form of business organization that
is most popular with foreign businessmen, because there is
flexibility, especially in joint venture situations, in formulating
how the company may be controlled and managed. The
company may be wholly owned by foreigners. However, in
those business activities reserved for Thai nationals, foreign
participation is generally allowed up to 49%.
The liability of the shareholders is limited to the par value
of the authorized capital. The liability of the directors,
however, may be unlimited if so provided in the company's
memorandum of association or the articles of incorporation.
The limited company is managed by a board of directors
according to the company's memorandum and by laws.
Although there is no established minimum level of
capitalization, the private limited company's capital must be
sufficient to accomplish its objectives. All of the shares
must be subscribed to, and at least 25% of the subscribed
shares must be paid up.
Thai corporate law has some features, which may be
unfamiliar to foreign businessman. Limited companies are
subject to corporate income tax at the general rate of 30%.
Private limited company's shareholders must never be fewer
than seven at all times.

Joint Ventures
The term "joint venture" refers to unregistered partnership,
in which at least one of the partners is a juristic person and
which carries on business whereby the parties maintain
joint accounts and share profits. A significant aspect of a
joint venture is that it is taxed as a juristic person at the
general rate of 30%.

Consortiums
A consortium is similar to a joint venture, in that the parties
to a limited degree act together in a business enterprise.
However, unlike a joint venture, they maintain separate
accounts and do not share profits. A consortium does not
pay income tax as such, but the parties to the consortium
pay their own taxes.

Branch offices
A foreign juristic person may do business in Thailand by
establishing a branch office and also complying with any
relevant laws relating to its business. If the branch office
intends to engage in a business that is restricted under the
Foreign Business Act, then it must apply for a license.
If the company establishing a branch is an American
company and can comply with the provisions of the Treaty
of Amity and Economic Relations, the branch office may
apply for a treaty protection letter from the Ministry of
Commerce and thereafter engage in any business, except
those excluded by the treaty. If the treaty is applicable, the
American company must apply for a certificate, but need
not apply for a license under the Foreign Business Act.
Since a branch office is for legal purposes a part of the
parent company, the parent is liable under civil and criminal
law for all the acts and omissions of the branch office.

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Factory establishment and operating licences
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A factory is defined as any premise, that uses machinery
equivalent to 5 horsepower or more, or that employs 7 or
more workers, with or without any machine, for manufacturing,
producing, assembling, packing, repairing, maintaining, testing,
improving, processing, conveying, storing or destroying
anything included in the classes or types of factories presently
listed in the ministerial regulations.
A factory may include a laboratory while workers may
include researchers.
Under the Factory Act B.E. 2535 (1992), factories are
separated into three groups according to the gravity of
impact of the factory operations to the public or the
environment, as follows:
Group 1 - Factories that can operate immediately
without prior government permission.
Group 2 - Factories that require prior notification of the
pertinent government authority before the business starts
operations.
Group 3 - Factories that require the application for a
factory license before the establishment of the factory.
The Factories Act also regulates the standards and
procedures for control of waste, pollution and any activity
that may harm the environment as a result of business
operations, and necessary documentation and data which
must be kept by factories to ensure compliance with the
Act and its regulations. Violators of the Act are liable to fines
ranging from $8,000 to $16,000 and/or prison sentences.
An application to establish a factory must be submitted to
the Ministry of Industry in Bangkok, or if the factory is
outside Bangkok, it may be submitted to the provincial
office. Full plans and details concerning the construction
and proposed purpose of the factory must be submitted.
Where required, an Environmental Impact Study must be
submitted as well and approved before a Factory Establishment
License may be granted.
After the construction of the factory, the manufacturer must
apply for a Factory Operating License. If on inspection it
appears that the factory and its machinery conform to the
Factory Establishment License, a Factory Operating License
will be issued.
Before the construction of a factory classified under Group 3,
the operator must obtain a factory license from the
Department of Industrial Works, Ministry of Industry. Application
for a license entails completing an official form, submitting
drawings and particulars of the factory, machinery, and
acceptable effluent treatment system, and attaching the
documents stipulated on the form.
The operator of a Group 3 factory must notify the competent
authority at least 15 days before a factory test-run
commences, and again 15 days before actual manufacturing
operations start. The factory license is valid up to the last
day of the fifth calendar year from the year of commencement
and is renewable. An application for renewal of the factory
license must be filed prior to the expiration of that license.
Licensees must also obtain prior permission from the
Ministry of Industry for any factory expansion, transfer of
machinery to other sites, or transfer of factory site. Permission
is likewise required in order to transfer, lease, assign, or
sell a factory operation.
Import and export controls
There are regulations on the import and export of goods
into and out of Thailand. Trade in certain items is restricted
through outright prohibition, imposition of duties or licensing
requirements.

Import controls
The Ministry of Commerce designates classes of goods
that are subject to import controls, which usually take the
form of permission and licensing. Although these controls
are being liberalized, at present more than 50 classes of
goods require import licenses from the Ministry of Commerce.
These categories are frequently changed through notifications
from the ministry. A license to import any of the specified
items must be secured from the Ministry of Commerce. In
addition to the Act imposing the above controls, a
number of goods are subject to import controls under
other laws. With relevance to biotechnology, these include:
The import of modern drugs requires prior licensing
from the Food and Drug Administration under the
Ministry of Health;
The Minerals Act stipulates that without appropriate
permission, an importer is prohibited from importing
tungsten oxide and tin ores and metallic tin in
quantities exceeding two kilograms;
The Cosmetic Act stipulates that for the purpose of
protection of public health, any importer of controlled
cosmetics must provide the name and location of
the office and the place of manufacture or storage of
the cosmetics, the name category, or kind of
cosmetics to be imported, and the major components
of the cosmetics.
Biotech hardware and chemicals and live specimens for
research are regulated by the Thai Customs Department.
The taxes for biotech hardware and chemicals are 5 % of
the total cost whereas those for live specimens are 10 %
of the total cost. Hazardous and exotic organisms are
quarantined by the Department of Medical Sciences,
Ministry of Public Health.

Export Controls
The Act Controlling the Importation and Exportation of Goods
authorizes the Ministry of Commerce to subject products to
export control. At present, close to 50 items require such
control. Certain goods require export licenses under other
laws, such as seeds, trees, and leaves of tobacco.
Import, export and possession of hazardous
substances in Thailand
The Act includes ten categories of hazardous chemicals as
follows:
Explosives
Flammable substance
Oxidizing agent and peroxide
Toxic substance
Substances causing diseases
Radioactive substance
Mutant causing substance
Corrosive substance
Irritating substance
Other substance either chemicals or otherwise
which may cause injury to the persons, animals,
plants, property or environments.
Hazardous substances are classified into four groups:
Category I hazardous chemicals for which the production,
import, export must be in compliance with the principles
and procedures promulgated. Category II hazardous chemicals
for which the production, import, export or being in
possession must be informed to the authorities. Category
III hazardous chemicals for which the production, import,
export or being in possession must be permitted. Category
IV hazardous chemicals for which the production, import,
export or their possession are legally forbidden.
No registration is necessary for chemicals of category I
while categories II and III need to be registered before
manufacture and/or import.
Importation, handling and disposal of radioactive
materials
The importation, handling and disposal of radioactive
materials is strictly regulated under the Atomic Energy for
Peace Act and radiation safety regulation. The Act and
regulations are enforced by the Office of Atomic Energy for
Peace of the Ministry of Science Technology and Environment
as well as the Department of Medical Science at the
Ministry of Public Health. The Office of Atomic Energy for
Peace looks after the utilization of radioactive materials and
other radiation sources, while the Department of Medical
Science looks after X-ray machines.
The Office of Atomic Energy for Peace is responsible for
licensing the utilization of radiation sources other than X-ray
machines. The responsibilities include authorization and
inspection, waste management and the information exchange.
Applications for importation, handling and disposal of
radioactive materials shall be submitted to Office of Atomic
Energy for Peace for approval according to sections 12 &
13 of the Atomic Energy for Peace Act B.E 2504.
Environmental legislation
The Enhancement and Conservat i on of Nat i onal
Environmental Quality Act B.E. 2535 (A.D 1992) is the
most significant environmental legislation. The Act continues
and expands the responsi bi l i ti es of the Nati onal
Environment Board (NEB) and created incentives for
environmental promotion and preservation, prescribes
penalties for polluters for the establishment of a fund for
promotion and preservation of environment quality and gives
the public a greater participation role in addressing
environmental problems.
The Act for the Cleanliness and Orderliness of the Country
B.E. 2535 (A.D. 1992) regulates and controls offences to
the environment deemed dangerous or unsightly. The Act
specifically prohibits the dumping of waste and waste
by-products into bodies of water.
Minister notifications and regulations issued under the
Factories Act B.E. 2512 (A.D. 1969) control the level of
effluent discharged by factories and restrict concentration
levels of chemical and/or metal pollutants to defined
parameters.
About the Author
Rouse & Co International provides a full range of intellectual
property services world-wide. We help manage patent
portfolios and advise on strategies that will enable the full
potential of the patents to be realized. Fabrice Mattei is a
partner and has been working in Thailand in the fields of
patent and biotechnology for the last 12 years.
Human Resources
A key success factor for Thailand's biotech industry is the
development and management of its biotech human resources.
Many initiatives are now in place to grow the local talent pool.
Thai professionals abroad are encouraged to return home to
contribute towards the growth of the local biotech scene.
Specifically, the National Science and Technology Development
Agency (NSTDA) has initiated a "Reverse Brain Drain Project"
to encourage Thai professionals with backgrounds in science,
engineering or medicine to return to share their technical
skills with their fellow countrymen. More information on the
project can be found at the NSTDA's website at www.nstda.or.th/
rbd (note: the information is written in Thai). In addition,
universities across the nation are beginning to offer more
relevant courses and degrees in the areas of science and
engineering. Both private companies and the Thai government
are offering scholarships to increase accessibility of education
in this exciting area.
To succeed in Thailand, companies starting up should have
a good understanding of the legal framework surrounding
labour issues and an appreciation of Thailand's cultural
perspective. There should also be a thorough planning
process to address common HR issues such as salaries
and benefits, employee relations, HR practices and termination
concerns prior to initiation of operation. Some of the
common employment laws and issues are detailed below:
Labour Laws
Designed to protect workers and preserve their rights, the
following legislations govern labour issues in Thailand:
Labour Protection Act
Labour Relations Act
The Act Establishing the Labour Court and Labour
Court Procedure
Provident Fund Act
Social Security Act
Workmen's Compensation Act
Thai Civil and Commercial Code
The Labour Protection Act underlines the minimum
employment condition requirements for an employee in the
private sector, including minimum and maximum working
hours, holidays, minimum wages, child and woman labor,
leaves (sick, maternity, military and business) and severance
pay. The Labour Relations Act provides the guidelines for
the establishment of unions and the negotiation of
employment contracts. The minimum age of employment
in Thailand is 15 years for standard jobs and 18 years for
dangerous or hazardous jobs.
Under the current labour laws, some of the benefits
that all employees are entitled to include:
13 national holidays per year.
1 day off per week (usually Sunday).
Minimum of 6 working days of annual paid
vacation upon completion of 1 year of employment.
Editorial biotech 3_4 6/10/06, 11:11 31
Up to 30 days of paid sick leave.
90 days of maternity leave. Pregnant employees are prohibited from working overtime, on holidays, or
between 10 p.m. and 6 a.m.
Maximum of 48 and 42 work hours a week for non-hazardous and hazardous works respectively.
Paid overtime compensation for extra hours but limited to maximum of 36 hours a week.
1 hour of rest after every 5 consecutive hours of work or a total of 1 hour of rest per work day.
Access to welfare facilities at the workplace, including medical and sanitary facilities.
Severance pay entitlement for employees with minimum of 120 days of service. Pay amount is dependent on
duration of service.
Duration of service Severance pay amount
120 days to less than 1 year 30 days of wage
1 - 3 years 90 days of wage
3 - 6 years 6 months wage
6 - 10 years 8 months of wage
> 10 years 10 months of wage
There is an on-going effort to translate the various Acts of Parliament from Thai into English. Translated versions of
some of these Acts can currently be found at the Thai Law Reform Commission (TLRC) website at www.lawreform.go.th
or the website of the Office of the Council of State at www.krisdika.go.th.
Guidelines on the criteria and rate of compensation benefits payment are stipulated in the Act. The general provisions
are as follow:
Category Range of Compensation Benefits
Cash compensation 2,000 to 9,000 baht
Medical expenses Up to 35,000 baht for normal case
Up to 50,000 baht for serious injury
Work rehabilitation expenses Up to 20,000 baht
Funeral expenses Up to 100 times of minimum daily wage rate
Workmen's Compensation Fund
In accordance with the Workmen's Compensation Act,
employers in Thailand are required to make annual
contributions to the Workmen's Compensation Fund.
The contribution rate varies from 0.2 1% of the employees'
annual wages and is dependent on the categorized risk rating
of the company and the companies prior work related
accident record. This fund is used to provide compensation
benefits to employees or their next-of-kins for injuries,
illnesses or deaths resulted from work related accidents.
Compensation benefits are categorized into 4 groups:
Cash compensation
Medical expenses
Work rehabilitation expenses
Funeral expenses
More details on the Workmen's Compensation Fund and
the various benefit entitlements may be found at the Social
Security Office website at www.sso.go.th/eng/index_en.html.
Minimum wages
Different minimum wages are applicable to businesses
located in the different provinces. The minimum wage per
day (effective January 1, 2006) ranges from 140 Baht in
the northern provinces of Phayao and Phrae to 184 Baht in
the capital, Bangkok.
Social Security Fund
The Social Security Act provides for the creation of the
Social Security Fund, which provides benefits to the
employee and his dependents for loss of work due to
non-work related injury, illness, maternity, disability, death,
or retirement. The fund is financed through monthly
contributions by the employers and employees (including
foreigners). Currently, each party contributes 4.5% of the
employee's monthly wage to the fund, up to a monthly
wage ceiling of 15,000 Baht. More details on the Social
Security Fund and the various benefit entitlements may be
found at the Social Security Office website at www.sso.go.th/
eng/index_en.html.
Provident Fund
Under the Labour Protection Act, employers with 10 or
more employees, and their employees, are required to
contribute to an employee welfare fund. This fund will be
used for lump sum or periodical payments to workers who
resign or are laid off. It also serves as compensation to the
dependents of employees who died in service.
Hiring Foreigners
Foreigners may not work in a number of occupations, including
the following, which are related to the biotechnology industry:
Agriculture, animal husbandry, forestry, fisheries, except
for work requiring special expertise, farm supervision
or labour in fisheries especially marine fisheries
Engineering in civil engineering concerning design and
calculation systemization analysis, planning, testing,
construction supervision or consulting services,
excluding work requiring specialized techniques
Work Permit
A foreigner who intends to work in Thailand will need to first
obtain a non-immigrant visa (usually business - category B)
to enter the country. Such a visa will entitle the holder to stay
in Thailand for a maximum period of 90 days. Non-immigrant
visas may be obtained from a Royal Thai embassy or
consulate by producing several documents, including an
employment letter from a company registered in Thailand. More
information on the visa application process may be found at the
Thai Ministry of Foreign Affairs' website at www.mfa.go.th.
With the aim of facilitating employment and immigration needs
of foreign investors, the Thailand's Board of Investment
established a One-Stop Service Center jointly with the Immigration
Bureau and the Department of Employment. The Center is
tasked to provide quick turnaround for visas and work permits
applications and renewals, usually within 3 hours upon receipt
of the complete and accurate documentations. In addition, the
center handles other transactions such as the issuance of multiple
re-entry stamps, changes in visa class and payment of fines.
It should be noted that the services offered by the One Stop
Service Center are only available to foreign investors, experts
and executives who have met certain criteria. Investors are
advised to contact the One Service Center for additional
information to see if they qualify for the Center's services.
The Center's contact info is as follow:
One Stop Service Center for Visas and Work Permits Office
of the Board of Investment
207 Glas Haus Building Ratchada, 3
rd
floor, Ratchadapisek
Road Din Daeng, Din Daeng, Bangkok 10400
Tel: 0-2693-9333-38 Fax: 0-2693-9352
E-mail: visawork@boi.go.th
The following sections have been extracted from the
website of the Board of Investment
http://www.boi.go.th./english/how/labor_issues_and_
important_addresses.asp
Legal Implications of Labour
Management
Thai labour laws provide for considerable freedom in
managing labour. As in many countries, it is not legal to
discriminate on the basis of age or sex. However, personnel
ads in Thai newspapers show employers narrowly defining
their needs: "The successful candidate will be male, under
35 years of age, not a member of a labour union, and at
least 150 cm in height, etc."
Furthermore, the government does not interfere with a
company's retrenchment policies when economic condi-
tions necessitate cutbacks. There is no "first in, last out"
requirement in Thailand.
Similarly, Thai employers have the right to transfer
employees to other work locations, provided the transfer is
not ordered with the exclusive intent to create hardship for
them. Refusal to transfer is legal cause for dismissal.

Employee records
An employer with 10 or more regular employees is
required to establish written rules and regulations in Thai
governing work performance. The regulations must be
displayed at the work premises within 15 days of the date
from which the number of employees reached 10 or more.
An employer with 10 or more regular employees is also
required to maintain an employee register in Thai with
documents pertaining to the payment of wages, overtime,
holiday work etc.
Tips on Recruiting and Developing Staff
The ability of a company to attract and retain staff is
enhanced by tailoring compensation packages to meet the
needs of individual employees. Increasingly, factors such as
work environment, organizational policies, relationships with
superiors, and defined career path influence decisions whether
to join or remain with a company. In a challenging living
environment such as Bangkok, these "quality of life"
factors are important.
Organizing training programs to upgrade skills helps to
motivate staff and demonstrates a company's commitment
to its employees. Admission to such programs can be seen
both as a reward for good performance and as part of the
total compensation package.

Recruiting Technically-skilled Manpower
There are two main English language daily newspapers
which support advertisements, both in English and in Thai.
Both the Bangkok Post and The Nation boast circulation
figures of close to 60,000 copies per day, and their
advertising rates are similar. In addition to these
mass-market dailies, there is an English-language daily, the
Business Day, which claims a daily circulation of
approximately 10,000. Prospective employees can be reached
through the print editions of these newspapers as well as
online classified advertisements on their websites.
The Department of Employment, Ministry of Labor and
Social Welfare also has a website which list job fairs and
employment opportunities. It is found at http://www.doe.go.th/
eng/index/html.
Several domestic and international personnel recruitment
firms operate in Bangkok. These companies also offer
services such as advice on issues of organizational
structure, labour relations, and the cultural implications of
managing labour in Thailand.
It is also recommended that companies develop contacts
with educational institutes to identify and court potential
candidates as early as possible. For companies with
ongoing manpower needs, establishing a network of
contacts can be especially valuable.
Besides tailoring compensation packages to individual needs
and emphasizing long-term and organizational benefits,
companies need to give high-end technical employees, such
scientists and engineers, work that are commensurate with
their skills. Given greater challenges and expanded roles in
areas like systems design and management, technical
personnel can become more productive and are more likely
to view themselves as an integral part of the company.
Concrete, long-term benefits are an effective retention tool.
Long-term benefits motivate personnel to work through
problems and to identify self-interest with company
interest. Committing resources to long-term benefits also
ensures that companies are able to realize increased
production levels from staff as they gain experience.
Withholding Tax
Certain types of income paid to companies are subject to
withholding tax at source. The withholding tax rates depend
on the types of income and the tax status of the recipient.
The following table shows some of the prevailing withholding
tax rates:
Types of income Withholding tax rate
1. Dividends 10 %
2. Interest 10 % if paid to associations
or foundations
15 % in other case
3. Royalties 10 % if paid to associations
or foundations 3 % in other case
4. Advertising Fees 2 %
5. Service and 3 % if paid to Thai company
professional fees or foreign company having
permanent branch in Thailand
5% if paid to foreign company
not having permanent branch
in Thailand
6. Prizes 5 %
It should be noted that government agencies are required
to withhold tax at the rate of 1% on all types of income
paid to companies.
The payer of income is required to file the return and
submit the amount of tax withheld to the District Revenue
Offices within seven days of the following month in which
the payment is made. The tax withheld will be credited
against final tax liability of the taxpayer.
Details of tax regime can be found at the Thai Revenue
Department website at www.rd.go.th. The website provides
comprehensive coverage on tax matters and is a valuable
online resource. Some of the more relevant sections are
summarized below:
Corporate Income Tax
Generally, companies are taxed on net profit derived from
business in Thailand at 30%. Various rate reductions are
available depending on the category of the company.
Personal Income Tax
Foreigners are considered Thai tax residents if they spend
180 days or more in Thailand during the calendar or tax
year. A tax resident is liable to pay tax on income from
sources in Thailand on a cash basis, regardless of where
the money is paid, as well as on the portion of income
from foreign sources that is brought into Thailand. Tax
rates for residents depend on their total taxable income
during the calendar year and range from 0% to 37%.
A non-resident is, however, subject to tax only on income
from sources in Thailand.
Value Added Tax (VAT)
The Value Added Tax (VAT) was implemented in Thailand
in 1992 as an indirect tax imposed on the value added of
each stage of production and distribution. Any person or
entity that regularly supplies goods or provides services in
Thailand and has an annual turnover exceeding 1.2 million
Baht is subject to the VAT. The current VAT is set at 7%.
An Overview of Bio-IP Legal Framework
in Thailand
In order to create a supportive infrastructure for biotechnology
industry development, the Thai Government has been
actively seeking to improve the laws governing the industry.
In particular, it is upgrading laws to provide a more favourable
environment for the protection and enforcement of
intellectual property, a vital element for the growth of
biotechnology.
There are five forms of intellectual property protection
relevant to the biotech industry, namely, patents, trade
secrets, plant variety, trademarks and copyrights.
However, the most used and relevant protection for the
biotechnology industry is patent.
Patents, utility models and designs
1

Patent for invention
Having an appropriate patent portfolio helps attract
investment and assures investors that when products and
services are finally marketed, exclusivity will be assured to
the company. A patent gives the patentee exclusive rights,
empowering him/her to prevent another from using,
making, selling or offering for sale, importing or exporting
the invention claimed in a patent. The right is territorial and
limited to the country where the patent is granted.
Biotechnological inventions are generally protected through
patents, which can include composition of matter claims
for instance on isolated nucleotide or amino acid sequences.
It is not permissible to claim methods of medical treatment
of humans and animals, or methods of diagnosis in relation
to humans or animals. However, a method for preventing a
disease can be patented.
The Patent Act does not allow for patents on plants and
animals. Patents on micro-organisms are only granted if
the organisms are modified. It further excludes patents on
plant varieties, which are protected under the Plant Variety
Protection. The law protects pharmaceutical products through
patent. Methods for the production of transgenic animals,
plants and micro organisms can also be patented as can
the organisms themselves as long as a discernable new
function or trait can be documented. For example, modified
Bt gene, isolated strains, purified strains etc.
What is the test for an invention to be capable of
patent protection? Are there separate tests for
biotechnology, medical device inventions?
The answer is no, the test is uniform. In order to obtain a
valid patent in Thailand, the subject invention must be
novel (that is, not known) and inventive at the date of filing
the patent application. A further requirement for a valid
patent is that the invention must be capable of industrial
application or be useful.
1
Patent Act B.E. 2522 as amended by the Patent Act (No.2) B.E 2535 and the Patent Act (No.3) B.E. 2542.
The novelty requirement can be troublesome. The invention
must not have existed somewhere (in or outside of
Thailand) in the form in which it is claimed. In the context
of biotechnology, the most obvious concern is the
patentability of natural products, which, at first glance,
appear to have pre-existed. However, if these materials can
be claimed in a manner, which distinguishes them from
their status as they occur in nature, there is no barrier to
patentability in properly constructed claims. For instance,
patents have been issued on DNA encoding erythropoietin,
pure TPA, DNA encoding TPA, and so forth.
The exclusive rights to the patentee are:
in the case of product patent, the right to
manufacture, use, sell, possess for sale, offer for
sale or import the patented products;
in the case of a process patent, the right to use the
patented process, manufacture, use, sell, possess
for sale, offer for sale or import the products which
are manufactured by the patented process.
The validity period of a patent is 20 years from the
application date.

Petty patent or utility model
Many technical creations involve a contribution of minor
additions to existing technology and do not comply with
the higher criteria of inventiveness required for a patent.
Product and process qualify for utility model protection.
Unlike patents for inventions, utility models are not required
to meet the inventiveness requirement. Practically, it means
that there is no need to prove prominent substantive
features and notable progress to existing or prior technology.
A product or process is eligible for registration as a utility
model if it is new and has industrial applicability. The
novelty requirement and industrial applicability are the same
as for an invention.
The period of protection for a utility model is six years from
the application date, with a possibility of extension for up to
four years.

Designs
Design protects the shape or appearance of an object,
composition of lines of colors giving a special appearance
to a product. Design protection is particularly relevant to
packaging, products shape etc. It must be new and
capable of industrial application. The owner of a design has
the same rights as the owner of a patent.
The validity period of designs is 10 years from the registration
date, not renewable.
Trade secrets
2
A trade secret will comprise any information, which has
commercial significance (valuable information in the
commerce) as a result of its confidentiality. In the
biotechnology area, compositions, tissue, experimentation
results, clinical trials results, process know-how, confidential
business idea, marketing plan etc may be protected by
trade secrets.
The ability of its holder to keep a secret is the ultimate
requirement. The holder is not protected against discovery
2
Trade Secrets Act B.E. 2545 (2002).
of the trade secret because of inadequate schemes for
ensuring secrecy. Thus, it is necessary to initiate and
maintain institutional practices which may or may not be
acceptable to affected parties, such as requiring employees
to sign confidentiality agreements, requiring visitors to wear
badges and be escorted, requiring exit interviews for
employees leaving the company, requiring identification of
what is and what is not under trade secret protection and
other burdensome and rather ill-defined measures to
assure confidentiality.
Given the high level of skill in biotechnology and the efforts
put in research and development, it is difficult to rely on
trade secret protection to provide a market advantage
although there are some rare and isolated cases proving
the contrary.
Plant Varieties Protection
3
The Plant Variety Protection Act 1999 (PVP) protects
conservers of local plant varieties as well as owners of
commercial plant varieties. Compensation has to be paid
for the use of local plant varieties in the development of
new commercialized varieties and when materials from
local plant varieties are extracted to gain ingredients for
medicinal or other products. There are other laws related to
the protection of specific biological resources and in order
to coordinate them, the Government has passed regulations
on conservation and use of biological resources on January
17, 2000 (see below).
There are four types of plant varieties protected under the
PVP:
New plant variety
A new plant variety, for example one created through
genetic modification, will only be granted protection if its
biological safety is proven. If a new variety causes damage
to community environment or community health, its owner,
by law, is liable for compensation.
The new varieties shall meet the following criteria in order
to obtain registration: distinctive, uniformity and stability.
For protection purposes, new varieties should not be
commercialized in or outside of Thailand more than two
months prior to the date of the application.
The protection period varies according to the nature of the
plant. For annual crops the protection is 12 years; for
perennial crops 17 years; and for trees, 27 years.
There are some exceptions to the exclusive rights granted
to applicants of new plant variety for research and farmers
uses.
Indigenous varieties
There are plant varieties developed by a community, which
have never been registered as new varieties. The community
has exclusive rights, after registration, and the access to
those varieties needs approval and negotiation for the
benefit of sharing with the community. The protection
follows the Convention on Biological Diversity guidelines.
Traditional local varieties
Traditional local varieties are those originated in the country
in which they are widely used by farmers. They are neither
new, indigenous varieties, nor wild species.
Wild plant species
Wild species are those that are found in nature and have
never been cultivated. Anyone who wants to make
commercial use of these varieties or their plant parts should
seek approval and negotiate fees and benefit sharing with
the relevant authority.
In addition to the Plant Variety Protection Act, there is the
Thai Traditional Medicine and Local Knowledge Protection
and Promotion Acts
4
that protect medicinal herbs, local
medicinal preparations as well as traditional knowledge such
as traditional medicine technology, diagnostic of illnesses
and diseases.
Efforts to conserve biodiversity are also restricted by
government policies and other legislations such as the
Forest Act B.E. 2484 amended, Wildlife Preservation and
Protection Act B.E. 2503 amended, the National Park Act
3
The Plant Varieties Protection Act B.E. 2542 (1999).
B.E. 2507, the National Forest Reserve Act B.E. 2507, the
Forest Plantation Act B.E. 2535, the Fishery Act B.E 2490
(1947) amended on 2528 (1985), the Plant Quarantine Act
b.e 2507 (1964) amended on B.E. 2542 (1999) as well
as the National Environment Quality Promotion and
Conservation Act B.E 2535 (1992) and the Plant
Reservation Act B.E 2542 (1999).
Copyright
5
Copyright protects creative works such as literary works,
computer programs, artistic work, musical work etc. No
one can reproduce or adapt the work for commercial
purposes without the priors authorization of the copyright
holder.
Unlike patent, copyright does not need to be registered.
The protection occurs upon the creation of the work and its
publication. However, it is possible to record it with the
Depart ment of I nt el l ect ual Propert y f or of f i ci al
acknowledgement.
Copyright protection is less relevant for the biotechnology
area. However, it may be used to protect the three
dimensional structures of proteins, user manuals,
drawings, diagrams, research report etc. Keeping good
records of such work is therefore important to prove
ownership.
Software can be protected by copyright and this is
particularly relevant to researchers and developers in the
bioinformatics area.
Trade and service marks
6
A mark is the brand name under which a product is sold or
a service is offered. Although the right to a trademark is
not relevant to the substantive protection of a biotechnology
invention, it is an invaluable right in the commercialization
of biotechnology inventions. When a product, process or
service is well named, the trademark can be used to protect
the market share. Thus a well thought out marketing
program will require the careful selection of a trademark.
The Department of Intellectual property is responsible for
receiving and examining trademark applications. Assuming
no complications, the Registrar normally grants registration
within 8-10 months from the application date. A registered
trademark is valid for 10 years and can be renewed for
unlimited subsequent periods of 10 years.
Registration of a trade or service mark in Thailand offers
the two main benefits:
Prevents others including competitors from
registering identical or similar marks in the same
or related class of goods or services;
Entitles the trade mark owner to take civil, criminal
or administrative actions in Thailand against
counterfeiters
Enforcing intellectual and industrial property rights
The enforcement of intellectual and industrial property rights
is under the exclusive jurisdiction of a specialized court: the
5
Copyright Act B.E. 2537 (1994).
6
Trade Mark Act B.E 2534 (1990) as amended by the Trade Mark Act (No.2) B.E 2543 (1999).
Central Intellectual Property and International Trade Court
(CIPITC). The CIPITC and its special procedural measure to
support the substantive laws on intellectual property have
helped improve the enforcement of IPRs.
An interesting feature of the CIPITC is the inclusion of
associate judges in the quorum. Some of them have
strong expertise and academic records in life science,
biotechnology and pharmacy. A quorum of judges in each
case is composed of two career judges and one associate
judge who has the same voting power and authority over
the case as a career judge. Associate judges help to guide
the career judges through the technical aspects of some
cases and they hold office for a term of five years.
The proceedings in the CIPITC are speedier than the ones
in the normal courts. The CIPITC may grant a preventive
injunction which orders the prospective counterfeiter to stop
or refrain from committing the infringement in the line with
the provisions in the Copyright Act (section 65), Trade
Mark Act (section 116) and Patent Act (section 77bis).
IP Issues related to Biotechnology
There are IP and IP-related legal issues that researchers in
Thailand must be aware of. The most important ones are
listed below:
Inventorship, ownership and compensation
It is a rare situation when only one person is involved in
the matter from start to finish and can go to the patent
office or his agent with a complete working invention and
say this is all my own work. Real life situations are
usually more complicated and the ownership of the rights
in an invention or creative work is regulated by law and by
contractual terms.
Invention made in employment
According to the Thai Patent Act
7
, employees invention is
owned by the employer if the invention is made in the
course of his employment. It is still important to include
appropriate provisions in employment contracts dealing
specifically with IP ownership. Employers generally require
to own any inventions and developments devised by the
employees during the course of their employment and
require the employees to take any step required to transfer
ownership and/or to assist the employer to protect and
enforce its intellectual property rights.
However, employee-inventors are entitled to compensation
where the invention is assigned to the employer and the
employer obtains benefits from the commercial exploitation
of the invention (e.g. licensing, assignment of the invention
etc.).
Commissioned inventions
Similarly commissioned or contracted inventions will be
owned by the person commissioning the work, provided
appropriate provisions are included in the commissioning
agreement.
The inventor shall always be named as such on the patent,
whether or not he owns any rights in it. The inventor must
be a real person and not a company or juristic person.
Joint-inventorship and ownership
It is not unusual for an invention to be co-invented. In that
case, more than one person may jointly hold a patent or
7
See supra note 1.
_
even trade secret.
Intellectual property rights can also be assigned to others.
About the Author
Rouse & Co International provides a full range of intellectual property services world-wide. We help manage patent
portfolios and advise on strategies that will enable the full potential of the patents to be realized. Fabrice Mattei is a partner
and has been working in Thailand in the fields of patent and biotechnology for the last 12 years.
Regulating Bioprospecting in Thailand
Thailand is a land rich in biodiversity. Out of 14 million
species of living organisms in the world, it is home to 1.27
million species. Legal protection of biodiversity in Thailand
has a long history. The country joined the international
efforts to protect biodiversity when it acceded the Convention
on Biological Diversity (CBD) on 12 June 1992 and later
ratifying it on 31 October 2003. The Convention is the
principal international treaty that governs bioprospecting
(the processes of securing the right to search and acquiring
rights to genetic resources). The CBD also establishes the
principles for sharing the benefits that are obtained from
the use of those resources, often referred to as Access and
Benefit Sharing (ABS). The rules on bioprospecting are
derived from the three primary goals of the pact: the
conservation of biodiversity, sustainable use of the
components of biodiversity and sharing the benefits arising
from the commercial and other utilization of genetic
resources in a fair and equitable way. Through the
enactment of the CBD, transfer of genetic resources is
increasingly being dealt through bilateral negotiation.
Thailand has set up its own domestic laws by adopting the
important CBD principle of ABS - access and benefit
sharing-into its jurisdiction.
The enactment of the Plant Variety Protection Law in B.E.
2542 (1999) marked the high point of the development of
legal protection of plant genetic resources. The Act was
introduced in Thailand in order to protect both new and
existing varieties. Existing varieties include wild varieties
1
,
local varieties
2
and traditional varieties
3
. In the case of local
varieties, the law requires the registration of local plant
species that are found traditionally in an area and local
plant species of villages. The rights of reproduction, species
modification, research, investigation, experimentation,
production, sales and exportation belong to the registrar.
And in order to pick, acquire or collect the subject plant
species for species modification, research, experimentation
and study, an agreement for benefit sharing is required
(article 48). In the case of domestic general varieties and
wild varieties, picking, acquisition and collection of parts
of plants for improvement of the species, research,
experimentation and study for commercial purposes will
require permission of the Department of Agriculture as well
as having a benefit sharing agreement in place (article 52).
In cases other than commercial purposes, the rules
stipulated by Plant Variety Protection Committee (article
53) must be followed.
The Act on Protection and Promotion of Traditional Thai
Medicinal Intelligence (enacted in B.E. 2542) can also be
regarded as bioprospecting law since statutory subject
matter includes herbs. The term herbs is defined as
plants, animals, bacteria, minerals, extracts of plants or
animals used, transformed, mixed or blended as drugs or
food for diagnosis, therapy, treatment or prevention of
diseases, or for promotion of the health of humans or
animals. The definition also covers the origin or the areas
in which the herbs exist. The Minister of Public Health has
the power to introduce rules, procedures and conditions on
certain activities involving controlled herbs. Without an
official permission, certain uses of controlled herbs are
illegal. The prohibited uses include commercial research,
exportation, commercialization and processing.
At present, a bioprospecting agreement is key in controlling
the use of genetic resources. In the past, most bioprospecting
arrangements involved foreign organizations paying Thai
organizations to collect and send bioresources and
sometimes to provide information such as location and
1
Wild varieties mean varieties that exist in a natural habitat but not widely cultivated.
2
Local varieties mean varieties indigenous to one particular community.
3
Domestic general varieties mean varieties widely available in the country, excluding new, wild and local varieties.
application. Based on the information, foreign companies had studied, developed and commercialized products. In
recent years, the concept of bioprospecting collaboration has changed. The concept of provider and taker has made
way for one of equal partnership. Both parties are encouraged to jointly plan and conduct collaborative projects.
Benefit sharing is also calculated on a fair and equitable basis which helps to create long term partnerships.
Having witnessed several incidents of biopiracy, many Thai organizations have taken great care in managing their
biological resources. For instance, the National Center for Genetic Engineering and Biotechnology (BIOTEC) realizes that
biotechnological research and development is directly associated with both domestic and foreign biological resources.
It is aware of the rules and regulations on access to biological resources as well as the need to prevent biopiracy. As
a result, the Center has introduced its Guideline on the Movement of Biological Material. The Guideline aims to prevent
biopiracy of Thai biological resources held at BIOTEC. Any acquisition of biological resources by BIOTEC staff must
comply with all applicable laws. The deposit of biological resources in BIOTEC must be accompanied by Material
Acquisition Agreements (MAA) while the transfer of materials to other organizations is controlled by Material Transfer
Agreements (MTA). These two important legal documents have been widely used in many research organizations.
Reference
1. Handa, S.S., a paper presented at Consultative Meeting of BIMST Countries on Biodiversity Conservation &
Sustainable Industrial Utilization of Medicinal Plants, 20-22 May 2002, Bangkok, Thailand.
2. Svarstad, H. and Dhillion, S.S. (eds.) Responding to Bioprospecting: From Biodiversity in the South to Medicines
in the North, Spartacus Forlag, Oslo, 2000.
This article is contributed by
Dr. Tanit Changthavorn of the National Center for Genetic Engineering and Biotechnology (BIOTEC)
Investment Promotion in Biotechnology
Biotechnology is very important to Thailand which aims to
become the supermarket of Asia and a hub for healthcare
services in the region. Therefore, the Board of Investment
gives high priority to this sector and encourages foreign
investment into this sector without any restriction on foreign
shareholding. In addition to non-tax incentives such as
granting permission for land ownership and facilitating
the application of visa and work permits, the Board of
Investment also offers the following investment incentives:
Biotechnology R&D
A project eligible for investment promotion under Category
7.12 Research and Development is offered exemption of
import duty on equipment and 8-year corporate income tax
exemption.
Biotechnology Laboratories
7.13 Scientific Laboratory or Category 1.22 Inspection
and Analysis of Diseases of Crops, Livestock, or Aquatic
Animals or both is offered exemption of import duty on
equipment and 8-year corporate income tax exemption.
Pharmaceutical
6.8 Pharmaceutical and Active Ingredient is offered
exemption on import duty on equipment. For corporate
income tax, if the project is located in Zone 1, it will receive
5-year tax holiday. If it is located in Zone 2 and outside of
an industry estate, it will receive 6-year tax holiday. On the
other hand, if it is located within an industry estate, it will
receive 7-year tax holiday. Finally, if the project is located
in Zone 3, it will receive 8-year tax holiday. However, the
amount of corporate tax exemption shall not to be more
than the investment amount excluding the cost of land and
working capital.
Bioenergy
1.26 Manufacturing of Alcohol or Fuel from Agricultural
Products is offered exemption of import duty on
equipment and 8-year of corporate income tax exemption.
Grading, Packaging & Storage
1.13 Grading, Packaging, and Storage of Plants,
Vegetables, Fruits, or Flowers, Using Modern Technology
is offered exemption of import duty on equipment and
8-year corporate income tax exemption. The amount of
corporate tax exemption shall not to be more than the
investment amount excluding the cost of land and working
capital.
Food and Beverage
1.11 Manufacturing or Preservation of Food or Food
Ingredients, Using Modern Technology is offered exemption
of import duty on equipment and 8-year of corporate
income tax exemption. The amount of corporate tax
exemption shall not to be more than the investment amount
excluding the cost of land and working capital. However,
if the project produces ready-to-eat or semi-ready-to-eat
food, there will be no restriction on utilization of the 8-year
corporate income tax exemption.
Chemical
A project is eligible for investment promotion under
Category 6.1 Manufacturing of Basic Chemical or
Category 6.2 Manufacturing of Other Chemical or both
will be offered the following tax privileges:
Project in Zone 1 will receive 50% reduction on
import duty on equipment if it is located outside
an industrial estate and both 50% reduction on
import duty on equipment and 3-year corporate
income tax exemption if it is located inside an
industrial estate.
income tax exemption if it is located outside an
industrial estate and exemption on import duty on
equipment and 7-year corporate income tax
exemption if it is located inside an industrial
estate.
Project in Zone 3 will receive exemption on import
duty on equipment and 8-year tax holiday.
The amount of corporate tax exemption shall not to be
more than the investment amount excluding the cost of
land and working capital.
Hospital
7.11.1 Hospital is offered the following tax privileges:
import duty on equipment if it is located outside
an industrial estate and both 50% reduction on
income tax exemption if it is located inside an
industrial estate.
income tax exemption if it is located outside an
industrial estate and exemption on import duty on
equipment and 7-year corporate income tax
exemption if it is located inside an industrial
estate.
Project in Zone 3 will receive exemption on import
duty on equipment and 8-year tax holiday.
The amount of corporate tax exemption shall not to be
more than the investment amount excluding the cost of
land and working capital.
Investment Promotion
The following are a number of recent projects approved by
the Board of Investment:
the Thailand Board of Investment (BOI)
Conducting Clinical Trials in Thailand
Investment in the life science and biotechnology sectors is
often high risk, particularly as innovations have long
gestation periods before a viable end use or product may
emerge. In light of this, investments need to be securely
protected within a robust intellectual property (IP) system.
Such an IP system should be fully integrated with research
activities and should be accepted by all involved as a
necessary main component for any country that wishes to
compete in the biotechnology arena.
At the forefront of Thailands efforts to promote biotechnology
is the Thailand Center for Excellence in Life Sciences (TCELS).
This organisation has taken up the challenge of attracting
high level investment to Thailands life science institutes
and centers particularly in the field of bio-pharmaceutical
products. TCELS is in the process of attracting high value
(in terms of revenue and knowledge generation) pre-clinical
testing and clinical trial activities using Thai facilities and
scientists. These activities are in line with the first key
milestone of the National Biotechnology Policy Framework
i.e. Thailand to become a main center for clinical testing in
Southeast Asia before 2007. In the last decade, Thailand
has already seen a large number of clinical trials of new
drugs being carried out at hospitals, medical centers and
research institutes nationwide. The Ministry of Public Health
(MoPH) has also made considerable efforts in the past few
years to persuade international pharmaceutical companies
to conduct clinical trials for newly developed drugs in
Thailand.
From a regulatory standpoint, the process of approving
clinical trials has not yet been centralised in this country.
Whilst drug regulation is centered at the Thai Food and
Drug Administration, one of the departments under the
Ministry of Public Health (FDA), this organisation does
not directly monitor, and is not directly responsible for
regulating, clinical trials of drugs in humans. Nevertheless
the FDA does play an indirect role. In addition, the
Department of Medical Services and the Department of
Communicable Diseases Control, both within the MoPH
have jurisdiction. The Ethical Review Committee for
Research in Human Subject of the MoPH (ERC) plays a
central role.
The FDAs primary jurisdiction to control the import of
drugs into the country for research purposes is frequently
used to indirectly bestow the FDA with the authority
(or responsibility) to regulate clinical trials of drugs in
humans.
To launch a clinical trial in Thailand, a drug developer/
sponsor must first select a research facility and a team of
physicians to conduct the study. In most cases, hospitals
and university medical centers are more apt to locate and
retain suitable participants for clinical trials than other
research institutes due to their ready access to a broad
range of patients and research volunteers. Therefore, most
clinical trials in Thailand are being carried out at these
establishments.
As required by law, a drug developer/sponsor needs to
obtain approval from an ethics committee overseeing
human research projects undertaken in an implementing
institution prior to launching a clinical trial. Approval must
also be obtained from the ERC and also from the ethics
committee of the research institute or university that will
conduct the trial. A protocol for conducting the clinical trial
must also be established and approved at the outset before
approval can be obtained. The proposed protocol is sent to
the Department of Medical Services within the MoPH for
review and consultation.
As for the ethics committees standard for review, although
there is no national standard, most ethics committees
follow the International Conference on Harmonisation (ICH)
Good Clinical Practice (GCP) guidelines for clinical trials,
promulgated by the World Health Organisation (WHO). In
general, a clinical trial proposal submitted to an ethics
committee would have to include the following information.
Background information of the proposed study
Objectives of the study
Justifications and expected benefits from the
proposed study
Location and duration of the study
Characteristics and the number of participants in the
clinical trial (with the details of sex, age, disease or
specific symptoms, etc.)
Inclusion and exclusion criteria
Discontinuation criteria
Discontinuation criteria for participants
Criteria for termination of the study.
Implementation and monitoring procedures, including
data collection and analysis.
Ethical considerations, including
Possible risks and preventive measures
Compensation, medical care and other services
to be provided to participants who may experience
complications
Information sheet and consent form for participants
Budget and source of funding
Typically, the review process takes approximately 2-3 months
(from date of submission to final decision). Once a drug
developer/sponsor receives an approval from the ethics
committee to conduct a study in humans, he may proceed
to request a licence from the FDA to import drugs into
Thailand for research purposes (in relation to the FDAs
licensing role of medicines, see below). Apart from an
official approval from an authorised (or FDA approved)
ethics committee, supporting documents to be submitted
with an application for licence to import drugs into Thailand
for research purposes include details of the drugs to be
imported, (pre)clinical trial report, a complete clinical trial
protocol, estimated amount of drugs required, and a power
of attorney. The application must be submitted to the Drug
Control Division of the FDA. It should also be noted that
this special import licence is valid for one year only,
regardless of the term of the ethics committees approval.
Therefore, if a clinical trial is not complete within a year, a
new import licence must be obtained.
At the moment, the MoPH is in the process of drafting new
legislation pertaining to government regulations of clinical
trials and national guidelines for research projects involving
humans. Details of the new legislation have not been
disclosed to the public. Nevertheless, it will likely cover the
establishment of a national ethics committee on human
research and its guidelines, rights of participants in a
research project and details of a contract that has to be
signed before a material transfer can take place. Although
the changes are on the way, it is difficult to predict when
the new legislation, regulations and/or national guidelines
will be implemented.
Marketing Approval for New Drugs
Outside of the conduct of clinical trials, the Thai
pharmaceutical control system is divided into a pre-marketing
and post-marketing phase. In the pre-marketing phase,
companies must obtain a licence to produce, sell or import
any pharmaceuticals into Thailand, as well as register their
product for actual sales. The FDA is the main agency in
charge of drug approval, registration and regulation. The
system of regulation is derived from the Drug Act B.E. 2510
(1967) together with its four amendments, ministerial
regulations and ministerial notifications. The fundamental
basis of Thai drug regulation is that all activities in relation
to the trading (i.e. importing, sales, production) of modern
medicines must be licensed by the FDA, and such licensees
must be Thai legal entities as set out in Section 12 of the
Drug Act, which reads:
No person shall produce or sell a modern drug or import
or order a modern drug into the Kingdom, unless he has
obtained a licence from the licensing authority. The
application for a grant of a licence shall be in accordance
with the rules, procedures and conditions prescribed in the
Ministerial Regulations.
In practice, the main types of licences available are:
A licence to produce modern drugs;
A licence to sell modern drugs;
A licence for modern drug wholesale;
A licence to sell only ready-packed modern drugs
which are not dangerous or specially-controlled
drugs
A licence to sell only ready-packed modern drugs
for veterinary use;
A licence to import or order drugs into Thailand.
It should be noted that the legislation uses the rather
ambiguous term modern drug. Nevertheless, this term is
defined to include drugs which are intended for use in the
practice of modern medicine, and will clearly cover
small-molecule and large-molecule drugs (such as biologics),
as opposed to herbal medicinal products and traditional
drugs.
The procedure for seeking approval for a modern drug will
in turn depend on whether the applicant is the drug
originator, or a generic producer. Drug originators face the
most onerous task as each element of drug safety, efficacy
and effectiveness must be demonstrated to the satisfaction
of the Drug Control Division of the FDA. In practice, there
are three core stages that must be followed in seeking
marketing approval for a new modern drug. New modern
drugs include new chemical entities, new indications, new
combinations and new routes of administration. With
biologics, the procedure to be followed for approval is
identical to the procedure discussed below, in respect of
new drugs and generic drugs. The main steps for new
drug (including biologics) approval are as follows:
Step One: Obtain Manufacture or Import Licence for a Drug
Sample
This first step involves the making of a formal application
to the Drug Control Division of the FDA to obtain a licence
to import a sample of the drug for which marketing
approval is sought. Alternatively, an application can be made
to obtain approval to locally manufacture the drug sample.
At present, Thailand does not have any real active
pharmaceutical ingredient (API) production facilities. A
significant proportion of manufacturing in the country takes
the form of drug formulation. In light of this, applications to
obtain import licences tend to be more common.
Step Two: Submit Application for Marketing Approval
Once the licence has been obtained to either import or
locally produce a sample of the new drug, a full marketing
approval application must be compiled to accompany the
samples of the new drug. The application is also submitted
to the Drug Control Division. This stage corresponds with
the NDA procedure before the US FDA and requires the
applicant to submit a complete dossier demonstrating the
efficacy, safety and quality of the new drug. The data and
documents to be submitted include:
Relevant application form
The proposed labels and leaflets (such as product
inserts)
Human and animal pharmacological study data
(pharmacokinetics, pharmacodynamics) and animal
toxicology studies
Data generated from the safety and efficacy studies
including clinical trial result dossiers
Full chemical (or biological) details of the new drug,
in addition to pharmaceutical data
Where the drug is to be imported, a certificate of free
sales from the country of origin
Where the drug is to be manufactured locally, a
certificate of raw materials for local manufactured
drugs
Updated status on the approval of the drug in other
countries.
It is common for the review process to last at least 12
months. At any time the drug originator may receive
questions. Whilst clinical trials need not be conducted
in Thailand for the purpose of supporting a new drug
application, the FDA does have discretion to require a local
study.
Since 1994 the Thai government has recommended that
production of pharmaceutical products take place according
to Good Manufacturing Practice (GMP). The MoPH now
mandate all public hospitals to ensure that drugs being
purchased are produced in accordance with GMP.
Safety Monitoring Period
Once the review of the new modern drug (biologic) has
been passed by the FDA, full unconditional approval is still
not available until the drug has passed through a Safety
Monitoring Period (SMP). Under this system, the newly
approved drug may only be sold in medical institutes (such
as government or private hospitals) under close medical
supervision. These limited circulation rights exist for a
minimum of two years but may be extended up to a total
of four years. The purpose of this SMP is to enable
distribution of the drug in the Thai market under conditions
that would enable the drug to be closely monitored and to
compile safety data, eventually leading to the grant of
unconditional marketing approval for the drug.
When a drug remains in the SMP, no generic version of
the drug may be registered nor can any bioequivalency
tests be conducted by any generic drug manufacturer. The
SMP effectively secures exclusivity for a drug manufacturer
_
for as long as the drug remains in the SMP, indirectly
providing the ability to exclude competitors from the market
in a manner similar to a situation had a Thai patent been
granted for that drug. However, a severe draw-back of the
SMP system is that a drug may not be listed in the
National List of Essential Drugs (NLED) if it is in the SMP
stage. This effectively curtails the market for the new drug
which in turn may cause difficulties in the collection
of sufficient post-marketing safety data to have the drug
removed from the SMP.
Approval of Generic Drugs
Generic drugs on the Thai market have accounted for a
significant proportion of overall drug sales. This trend is
likely to continue in light of the governments health care
policy which seeks to make affordable medicine available to
all. While drug originators have traditionally faced generic
competition with respect to the more conventional types of
small molecule modern drugs, generic competition is now
increasing in the field of biologics.
As is the case in many countries, an abbreviated form of
approval exists in Thailand for generic versions of drugs
that have already obtained marketing approval in Thailand.
In essence there are two types of generic drug approval,
depending on whether a reference originator has already
been approved in Thailand, or if the generic is an entirely
new non-patented drug on the Thai market. In such a case
a protocol on the local conduct of bioequivalence studies
must be submitted and approved. The common element in
both forms of generic approval is that the applicant need
only submit bioequivalence data as opposed to conducting
rigorous trials and tests to prove safety and efficacy of the
chemical entity or biological molecule. In other words, the
Thai FDA does not require the generic applicant to
reproduce clinical trials or pre-clinical tests. The primary
steps involved in generic approval are as follows
Step One: Obtain Manufacture or Import Licence for a Drug
Sample
Similar to the first step to be followed by new drug
originators, this stage involves the formal application to the
FDA for a licence to import a sample of the drug/biologic
for which marketing approval is sought. Alternatively, an
application can be made to obtain approval to locally
manufacture the sample.
Step Two: Obtain drug quality and analytical control method
approval
Various details as to the drug production process to be
used in producing the generic are submitted as part of the
application process. Most of these details concern the
demonstration of quality of the drug. Amongst the details
are manufacturi ng methods, i n-process control s,
specifications of the active ingredients and excipients.
Information as to the storage conditions of the drug and
details as to the stability of the drug are also required.
Step Three: Submission of Generic Product Registration
Request
The final stage involves submission of a formal application
for a drug registration certificate. This directly corresponds
to the NDA procedure before the US FDA in that this stage
requires the filing of a full dossier in support of the
application.
It is possible to obtain generic approval within six month
from the submission of the documents in step three.
However, in practice, it can take up to another extra six
months to conduct the requisite bioequivalence studies.
Relationship between
RegulatorySystem and IP Laws
Thailands clinical trial system and drug regulatory system
operate independent of the IP system. Whilst the separation
of drug regulation and IP is common in many countries,
there is a tendency for healthcare authorities to consult
with IP regulators to avoid potential conflicts in practices.
Other countries, such as Hong Kong and Singapore, have
also sought to enshrine legislative safeguards. In Thailand,
there is still a weakness in communication between the
Department of Intellectual Property (responsible for
granting and maintaining patents) and the FDA. This may
affect the attractiveness of Thailand as a destination for the
development and launch of new products because drug
originators fear that generic competition may be facilitated
at an earlier than expected stage in a new drugs product
life cycle. An overview of the some of the main IP issues
intersecting the regulatory system is as follows:
Patents, Relevance & Weaknesses
Thailands Patent Act became 25 years old in 2004. Despite
its age, patent law is still regarded as a relatively new area
within the Kingdom, especially when compared to many
developed nations where extensive patent laws have existed
for many decades. Early proposals for a patent system in
Thailand, dating as far back as 1913, met with little
success. After a 1964 Supreme Court judgment directed
that patents were not recognised as legal rights, the need
for patent law became more pronounced. But it was not
until September 1979 that the Patent Act B.E. 2522 (1979)
was finally enacted. This legislation remains the core patent
law in Thailand today despite having undergone two
substantial amendments in 1992 and in 1999.
Thailands patent laws were crafted in a manner that was
thought to complement the technological progress
development strategy of the Kingdom. As part of the
strategy, the original section 9 of the Patent Act contained
a clear prohibition against the patenting of foods,
beverages, pharmaceuticals or pharmaceutical ingredients.
In effect, it ruled out the possibility of obtaining a patent for
new pharmaceutical products (including biologics). The
exclusion was much in line with the patent law of many
developing countries in the pre-WTO/TRIPS era. It was
argued that by excluding pharmaceutical products from
being patentable, growth in the domestic pharmaceutical
industries would result. Domestic drug companies would
be permitted to legally copy drugs protected in developed
markets, thereby enabling the domestic industry to develop
and grow exports. With increased exports, income and
profits could be generated and eventually find their way to
fund research activities, thereby promoting technological
development.
On the other hand, manufacturi ng processes for
pharmaceutical products were patentable. This enabled new
processes for producing, maintaining or improving the quality
of a pharmaceutical product to be protected. However, this
protection was regarded as weak as non-infringing
work-around to manufacturing processes could be
developed.
As a result of the perceived weakness of process
patent protection for the pharmaceutical products, many
pharmaceutical industry groups pressed for reform of
the patent system in Thailand to extend protection to
pharmaceutical patents. In 1992 amendments to the Patent
Act finally enabled pharmaceutical products to be
patented in Thailand for the first time. Furthermore, the
amendments also extended the protection for patents from
15 to 20 years.
Pipeline Protection
One of the weaknesses of the 1992 amendments was that
the ability to obtain patents for drug products was not
applied retroactively to products already on the market
i n overseas j uri sdi cti ons. Patent appl i cati ons for
pharmaceutical products that were current in overseas
jurisdictions at the date of the amendments to the Patent
Act could be extended to Thailand provided that the
application was filed within 12 months of the priority date.
For other applications or patents in other countries, no
protection existed. As a consequence, in October 1993, a
form of pipeline protection for pharmaceutical products was
introduced. The compromise that was reached was not an
amendment to the Patent Act but the introduction of
administrative rules to be applied by the FDA in the
approval of new drug products for sale on the Thai market.
In effect, the rules enabled proprietors of drugs patented
abroad between 1986 and 1991 (and for which the patent
was still in force), but never distributed in Thailand to
obtain, in effect, a form of limited marketing exclusivity for
their drugs for the Thai market by using the SMP system
as outlined earlier.
Bolar Provisions & Generic Competition
The exclusive patent rights of the drug innovator should, in
theory, enable him to prevent third parties from conducting
any activities in relation to the patented drug with a view to
obtaining marketing approval from the FDA while the drug
is still under patent. To this end the patent rights of the
drug innovator should also permit restriction of third partys
preparatory activities such as the development or import of
the generic drug for the conduct of pre-clinical tests, and
the conduct of the clinical trials itself. However, Section 36
of the Patent Act contains a number of broad exceptions to
patent infringement including
(4) Any act connected with an application for drug
registration wherein the applicant has the objective of
producing, selling or importing the patented medical
products after the expiry of the patent
This exception, which has come to be known as a Bolar
Provision effectively enables generic drug developers in
Thailand to develop, import and conduct clinical trials and
other activities for the purpose of registering a generic
version of patented drug with the FDA while the original
drug is still under patent.
Patent Linking
At present the FDA does not have a legal obligation to
determine whether a particular drug formula or active
ingredient is under patent in Thailand when deciding on
whether to grant marketing approval for a generic drug. In
effect, the FDA is free to examine and grant marketing
approval for a generic version of a drug even while the
reference drug is under patent protection in Thailand.
Pharmaceutical innovators are concerned that the freedom
with which the FDA can grant marketing approval while a
drug is under patent protection can accelerate the process
by which a generic drug can enter the market and compete
with the branded drug. If the FDA is required to ensure
that all generic drug marketing approval applicants are
off-patent, the drug originator will then have a longer period
of time after the patent expires to recoup investment costs for
the development of the drug. Patent linking is widely
regarded as a modern necessity and is firmly enshrined in the
laws of some prominent biotechnology players including
the US, EU countries, Australia, Singapore and Hong Kong.
Patent Term Restoration
The term of protection for a patent owner in Thailand is 20
years from the earliest application date, with no possibility
for an extension. Patent applications must be pursued
directly in Thailand as the country is still not a member of
the Patent Cooperation Treaty. Thailand is also a full
examining country, meaning that full substantive
examination of all patent applications must be conducted
before a patent can be approved. Due to resource
limitations, the Department of Intellectual Property outsources
much of the examination work to the Australia patent office.
In the event that an unreasonable delay occurs in the
granting of a patent (i.e. a delay often in excess of four
years) or in the approval of a drug (i.e. a delay frequently
in excess of two years), the effective patent life may be
dramatically curtailed and hence severely impede a drug
developer from using the patent to recoup costs of
development.
To encourage drug developers to continue developing new
medicines and to discourage patent offices and drug
regulators from incurring unreasonable delays, many
countries operate a system of patent term restoration which
provides patent owner with a limited extension (often capped
at between 3 and 5 years) of the patent term, to
compensate for such avoidable delays. Unfortunately, this
is still unavailable in Thailand.
Protecting Pre-Clinical & Clinical Trial Data
The extent to which a generic applicant can rely on test
data on file with the FDA has also proved to be a thorny
issue. In practice many countries recognise the extreme
cost of developing such data and hence confer a limited
period of protection to drug originators. These laws often
confer exclusivity rights on the drug inventor in relation to
the clinical test data it has submitted, effectively excluding
generic manufacturers from relying on the data for a
limited time. The requirement to protect such test data is
also firmly enshrined in the TRIPS Agreement, although the
parameters of this right are not clear. In the EU, data
protection/exclusivity periods of up to ten years exist, while
in the US the exclusivity period can be up to 5 years.
Recently the Thai Government enacted the Trade Secrets
Act 2002 (BE 2545). This legislation creates a legal
framework for the protection of trade secrets and other
confidential information, rendering the unauthorised use and
disclosure of such information an actionable offence
punishable by civil and criminal remedies. Section 15 of
the legislation specifically addresses the issue of data
exclusivity in respect of data submitted to the FDA for drug
approval purposes. The Act recognises that such
information may amount to a trade secret and that the
trade secret owner would have the right to request the FDA
to maintain the confidentiality of the information. Upon
such request, the FDA would have a duty to maintain the
trade secret from being disclosed, deprived of or used in
unfair trading activities, in accordance with the regulations
prescribed by the Minister.
Future Directions
The potential for a free trade agreement (FTA) between
Thailand and the United States (TUSFTA) has long
been in the offing. But it was not until February 12, 2005
that initial formalities were completed when US Trade
Representatives notified the US Congress of their intention
to commence negotiations with the Thai Government.
TUSFTA is welcomed by many businesses and industries
as it will ensure the attractiveness of Thai products in the
US market. It is also widely expected that a key chapter of
the pact will contain a number of obligations on Thailand to
modernise its intellectual property regime in line with
international trends and in compliance with Thailands
original obligations arising from accession to the TRIPs
Agreement. In essence, TUSFTA will present an ideal
opportunity for Thailand to enhance the attractiveness of
the country through the strengthening of its laws and
procedures, making it a safe and secure destination for
foreign direct investment, particularly in the biotechnology
and pharmaceutical fields (in addition to other areas such
IT, automotives and agriculture).
Thailand is capable of becoming a major player in the
regional biotechnology sector. In addition to a strengthening
of drug regulation in line with international best practices
and procedures, Thailand must firmly recognise the need
for and role played by IP.
About the Authors
Edward Madden (emadden@tillekeandgibbins.com) is
director within the Intellectual Property Department of
Thailands oldest law firm Tilleke and Gibbins. He acts on
behalf of a number of leading pharmaceutical companies
such as Merck & Co, GSK and Schering Plough and is part
of the advisory team to PReMA.
Siraprapha Rungry (siraprapha@tillekeandgibbins.com) is a
legal consultant within the Intellectual Property Department
of Tilleke and Gibbins and is separately assisting the
National Innovation Agency with respect to innovation
promotion and IP commercialisation.
Biosafety Regulation
Thailand is currently not trading in genetically modified
plants, except for research purposes. It acceded the Cartagena
Protocol on 10 November 2005 which was entered into
force on 8 February 2006. The treaty required Thailand to
put in place a legislative framework for the entire country
so that it can fully participate in this multilateral approach
to managing the potential risks of LMOs. Such a
framework would define how Thailand can regulate and
promote modern biotechnology at a faster pace than before.
The country has made good progress as the drafting
Committee has already approved the draft Biosafety Act
(issued on 29 June 2006) which is currently under public
consultation and consisting of 103 Articles in 10 sections.
In addition, the Office of Natural Resources and
Environmental Policy and Planning has been nominated as
the National Focal Point for the Protocol and Biosafety
Clearing House (see more detail in http://bch-thai.onep.go.th/
index_en.html).
Biosafety Guidelines for Research and Development
Thailands current regulatory system does not specifically
prohibit or control any research, development and
production of GM crops developed domestically. The Biosafety
Guidelines for Work Related to Modern Biotechnology or
Geneti c Engi neeri ng (for more i nformati on vi si t
http://biosafety.biotec.or.th/?sw=topicview&id=637), a
non-binding set of rules proposed and used by BIOTEC
since 1992 was the first set of guidelines in biosafety that
researchers and developers (including plant breeders
who involve in genetic engineering) in the country were
encouraged to follow.
To effectively implement those guidelines, the Central
Biosafety Committee (CBC) was established. Subsequently,
sub-committees for specific areas such as for plants, food
and micro-organisms were also set up. The committees act
as technical supervisor on biosafety for the Institutional
Biosafety Committees (IBC) which have been encouraged
to be set up at various research institutes as well as for the
Competent National Authorities such as Department of
Agriculture and Food and Drug Administration.
The figure 1 below shows the process, for example, for
research project approval by the IBC for type 1 and type 2
research project categories. Only type 3 category
projects which may cause harmful effects to researchers,
communities and environment will be approved or be
recommended by the CBC. Funding agencies will not grant
the research project unless the approval letter from IBC/
CBC is attached.
Figure 1. Research project approval process
Biosafety-related Legislation
Thailand currently has no specific laws on biosafety. But
the Ministry of Natural Resource and Environment (MNRE)
is developing a bill for biosafety law which is expected to
be finalized soon. In its absence, some related acts are
applied as follows:
1) Plant Quarantine Act B.E. 2507 (1964)
The notifications under this act are promulgated to cover
aspects of LMOs issues that are not clearly stated in this
act. Eighty nine species of LMOs are prohibited to be
imported into and transported across the Kingdom, except
for research and development granted by the Director-
General of the Department of Agriculture in compliance
with guidelines on import and transit of prohibited materials.
2) Plant Variety Protection B.E. 2542 (1999)
New plant species and the holder of the plant variety right
are protectable under this act. Living modified plants
capable of registration shall be assessed for potential risks
3) Food Act B.E. 2522 (1979)
According to this Act, the Minister shall be empowered to
promulgate notifications for controlling food by reference to
the class and kind of food produced for sale, import for
sale, or sale including condition and methods of labeling,
principle and methods of advertising on the label.
Information on biosafety-related legislation can be found at
http://bch-thai.onep.go.th/law_list_e.html
Regulation on GM Plant/Seed in Plants
In accordance with the Plant Quarantine Act B.E. 2507
(1964) 1964 as amended in 1999, importation of GMOs
into Thailand as a plant is prohibited. To comply with the
Plant Quarantine Law concerning transgenic plants as the
prohibited materials, the MOAC has issued many rules and
measure, as follows:
1) Ministerial Notification
MOAC issued The Ministerial Notification B.E. 2543 (2000)
under the Plant Quarantine Act B.E. 2507 amended by
Plant Quarantine (No.2) B.E. 2542 specified 89 GM-plant
species as prohibited materials for importation unless for
experiment and research purposes that requires the import
permit issued by DOA. However, soybean and corn grains
are exempted from the ministerial notification in light of
food, feed and industrial utilization.
2) DOA Notification
DOA has issued 3 notifications, firstly is an application
guideline for the importation of prohibited transgenic plants;
secondly, is to certify crop production in Thailand as
Non-GMOs (list of 159 plants), and thirdly is to certify that
imported plant propagated materials are not derived from
genetic modification. More details on the application
guidelines are as followed:
Procedures for Importation of Transgenic Plants.
Application of imported transgenic plants into the
Kingdom has to be submitted to the Director of
Agricultural Regulatory Division (ARD). The plant
quarantine authority will review and check all the
necessary documents in accordance with ministerial
and DOA notifications. Furthermore, the Director of
ARD will submit the application accompanied with
information and technical documents to the DOA
Biosafety Committee for consideration. The
Committee shall appoint four to five committee
members to evaluate and examine all technical
information and make recommendation to the
Committee. Finally, the Director General (DG) of
DOA on the advice and recommendation of the
Biosafety Committee will make a decision whether
to approve or reject the application.
Approval of Transgenic Plants. In accordance with
the Plant Quarantine Act B.E. 2507 (1964)
amended (No.2) B.E. 2542 (1999). The importation
of prohibited material shall require the permission
from the DG of DOA only for the purpose of
experimentation or research in related to the
following processes:
The experiment must be carried out under the
strict control of the Field Inspection on Biosafety
Working Group responsible for inspection and
monitoring in laboratory/greenhouse, closed
containment and field trial. At present, there are five
Field Inspection on Biosafety Working Groups; rice,
maize cotton, tomato and papaya & cucurbitaceae.
Rules and procedures of biosafety guidelines will
be observed and strictly implemented.
The working group will conclude and report the
testing result at each step to the Risk Assessment
Sub-Committee to evaluate the risk and safety.
Risk Assessment Sub-Committee will submit the
evaluated report to the Biosafety Committee for
consideration.
DG-DOA by recommendation and advice of the
Biosafety Committee will submit an opinion to
deregulate certain GM-plant to the Minister of
Agriculture and Cooperatives if no adverse
effects are found.
The Minister of Agriculture and Cooperatives will
have a final decision whether to deregulate or not.
The biological risk assessment of imported transgenic
plants shall take into account the following factors:
The experiment will be conducted in an enclosed
environment on its first introduction.
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Developing effective public relations
strategies for the Bioindustry
How can your organisation stand out from the crowd? Do
you need to boost your companys public image? How can
your company let potential customers learn about its
products and services?
In todays competitive environment, getting noticed for the
right reasons and by the right people is crucial to any
organisations success. This is especially true in the
bioindustry where savvy biotech organisations often use
public relations (PR) as a tool to help them change the
opinions, mindsets and actions of the public, customers,
partners and investors. PR is very effective if used well,
but what exactly is it?
Public Relations-Back to the basics
PR can be defined as the planned effort that helps develop
a communication channel between an organisation and its
publics. Typically, this is done on a long-term, sustained
basis so as to build up better understanding, acceptance
and cooperation.
There are a number of different ways that PR can be used.
This includes:
Media relations - This involves disseminating information
through media, such as newspapers, magazines, radio,
television and on-line portals. The main benefit is that
information is effectively disseminated, in a manner that is
generally perceived as being accurate, as it is from an
independent third party. For example, having a favourable
write up of a new product in a newspaper is likely to be
perceived positively by more people than a paid
advertisement or a corporate brochure. Another benefit is
that there is usually no direct cost to the organisation for
publicising such material, though costs are incurred through
organising press conferences, writing press releases or
arranging media interviews.
Advertising - Like media relations, advertising involves
disseminating information through similar media. The key
difference is that advertising is characterised by payment to
the media. This results in the advantage of control-control
over the content, placement of content and timing of
release of information. For example, a lab equipment
company could put regular placements throughout the year
of its products in relevant industry magazines. However
advertising can result in high costs, both for the placement
of the advertisement, as well as to design companies for
creating unique and memorable advertisements.
Corporate material - This includes brochures, posters,
annual reports, newsletters, websites and other corporate
information produced by the organisation. This material
allows the organisation to develop its messages, according
to the specific way that it wants. It can also help to build up
the image and branding of the organisation.
Organising of events - This allows an organisation to reach
out to its target audience directly, instead of going through
different forms of media as the previous activities. It
includes taking part in large scale international conferences
and exhibitions, or coordinating specific events related to
an organisation, such as industry-specific seminars, or the
launch of a product. As organisations are likely to meet
existing and potential clients, investors, collaborators,
suppliers, competitors and the general public at such events,
they must be well prepared in terms of information that
they are presenting.
Organisations in the bioindustry frequently use a range of
PR activities, as communication for this industry is crucial.
This industry is often associated with products and services
relating to health and quality of life of mankind, and
breaking scientific information into understandable layman
terms is vital. Research organisations must keep the
scientific community informed of their latest developments,
in order to further advance their research. Furthermore, as
the industry frequently requires significant investments, which
take a long time to bear fruits, establishing good PR can
open doors for companies seeking financial support.
Tips of the trade
For organisations that rely on PR activities for their
continued well-being, it is recommended that they employ
qualified PR staff or outsource the work to a professional
company. However for those organisations with limited
resources, handling PR work in-house may be a good
option. Here are some suggestions should you need to
implement your own PR work:
1) Identify at the start who is your target audience,
what are your key messages and what your end
goal is.
2) When writing a press release, it is preferable to
ask non-technical staff to draft it, as usually you
are writing for a journalist who may not be
technically trained. Start with the most important
information first, and fit in the Why, When, Who,
What and How. Use simple language and explain
all technical terms. Use Annexes to provide
additional details.
3) If the content is highly technical, target the trade
publications and industry specific media.
4) Hold a press conference if you believe there will
be different media interested and many questions
will be asked. If the news is more straightforward,
a simple press release should suffice.
5) Identify your spokesperson(s) and all media
communication should go through him or her.
Ideally your spokesperson should be the highest
ranking and most relevant person, e.g. CEO if you
announcing corporate information, CSO if you are
announcing research or scientific information. If
you have more than one spokesperson (e.g. CEO
and CSO), ensure that they are updated on the
latest developments, to avoid the confusion of
giving out conflicting information. Prepare your
spokesperson with FAQs and possible sensitive
questions.
6) Be aware that media are frequently on tight time
lines. If a journalist has a question that you need
more time to answer, check with him or her on
the time line, and stick to it.
7) Once you have established a contact with a
journalist, maintain a good relationship with him
or her. This can be done by contacting the same
journalist with subsequent news, giving them a
few days advance notice should you have a
significant announcement and follow up with thank
you emails and phone calls after your news is
published.
By using a combination of the different types of PR
activities, biotech organisations can generate greater
awareness and more importantly, support amongst their
target audience.
Effective PR will enhance your organisations competitiveness;
make it an essential part of your organisations suite of
business tools.
About the Author
Chan Yiu Lin is the Principal Consultant of Greener Grass
Communications, a public relations firm specializing in
marketing communications strategies for technology-based
companies. She is familiar with life sciences scene and has
assisted clients in launching their presence and increasing
awareness in Asia.
To contact Yiu Lin, email her at yiulin@greenergrass.com.sg
AGRICULTURAL RESEARCH DEVELOPMENT
AGENCY (PUBLIC ORGANIZATION)
2003/61 Phaholyothin Rd
Ladyao, Chatuchak
Bangkok 10900
Tel: (66) 2579 7435
Fax: (66) 2579 7235
Email: veerasuda@arda.or.th
Website: www.arda.or.th
BIOTECHNOLOGY ALLIANCE ASSOCIATION
Rm 308, 3/F, Kasetsart University Alumni Association
Bldg. 50 Paholyothin Rd.
Ladyao, Chatuchak
Bangkok 10900
Tel: (66) 2940 5264
Website: www.thaibaa.org
DEPARTMENT OF AGRICULTURE
3/F, The Center of Operation Training and Conveying
Technology Bldg.
Chatuchak
Bangkok 10900
Tel: (66) 2579 0151-7
Email: itc@doa.go.th
Website: www.doa.go.th
DEPARTMENT OF INTELLECTUAL PROPERTY
44/100 Nonthaburi 1 Rd.
Muang
Nonthaburi 11000
Tel: (66) 2547 4632
Website: www.ipthailand.org
DEPARTMENT OF LIVESTOCK DEVELOPMENT
Payathai Rd.
Bangkok 10400
Tel: (66) 2653 4444
Fax: (66) 2653 4925
Email: foreign@dld.go.th
Website: www.dld.go.th
DEPARTMENT OF MEDICAL SCIENCES
88/7 Tiwanon Rd.
Muang
Nonthaburi 11000
Tel: (66) 2589 0022
Website: www.dmsc.moph.go.th
DEPARTMENT OF SCIENCE SERVICE
75/7 Rama VI Rd.
Ratchathewi
Bangkok 10400
Tel: (66) 2201 7000
Fax: (66) 2644 5698
Website: www.dss.go.th
EXPORT-IMPORT BANK OF THAILAND
EXIM Bldg.
1193 Paholyothin Rd.
Phayathai
Bangkok 10400
Tel: (66) 2271 3700
Fax: (66) 2271 3204
Email: info@exim.go.th
Website: www.exim.go.th
Useful address 6/10/06, 11:20 67
FOOD AND DRUG ADMINISTRATION
88/24 Tiwanon Rd.
Muang
Nonthaburi 11000
Tel: (66) 2590 7000
Website: www.fda.moph.go.th
FOOD SCIENCE AND TECHNOLOGY ASSOCIATION
OF THAILAND (FOSTAT)
113 Thailand Science Park, Phaholyothin Rd.
Klong Nueng, Klong Luang
Pathumthani 12120
Tel: (66) 2564 6700 EXT 3119
Fax: (66) 2564 6701
Email: fostat@biotec.or.th
Website: fostat.biotec.or.th
INDUSTRIAL ESTATE OF THAILAND
618 Nikommakkasan Rd.
Ratchthewi
Bangkok 10400
Tel: (66) 2253 0561
Fax: (66) 2253 4086
Email: ieat@ieat.go.th
Website: www.ieat.go.th
INDUSTRIAL PARK CENTER, KING MONGKUTS
UNIVERSITY OF TECHNOLOGY THONBURI
The 4th Chemical Engineering Bldg.
91 Suksawas 48 Rd. Bang Mod, Tung Kru
Bangkok 10140
Tel: (66) 2470 9719
Fax: (66) 2452 3455
Website: www.kmutt.ac.th/organization/Park/#Ind
INSTITUTE FOR SMALL AND MEDIUM
ENTERPRISE DEVELOPMENT (ISMED)
99 Gym 1
Thammasat University Rangsit
Klong Luang
Pathumthani 12120
Tel: (66) 2564 4000
Website: www.ismed.or.th
MARINE BIOTECHNOLOGY RESEARCH UNIT,
CHULALONGKORN UNIVERSITY
254 Phayathai Rd. Pahatumwan
Bangkok 10330
Tel: (66) 2218 5279
Fax: (66) 2254 7680
Website: www.biotec.or.th/marine/
NATIONAL CENTER FOR GENETIC ENGINEERING
AND BIOTECHNOLOGY (BIOTEC)
113 Thailand Science Park, Phaholyothin Rd.
Pathumthani 12120
Tel: (66) 2564 6700
Fax: (66) 2564 6701
Website: www.biotec.or.th
NATIONAL FOOD INSTITUTE
2008 Charansanitwong 40 Rd.
Bang Yi Khan, Bang Phlat
Bangkok 10700
Tel: (66) 2886 8088
Fax: (66) 2886 8106-7
Website: www.nfi.or.th
NATIONAL INNOVATION AGENCY
73/1 Rama VI Rd.
Rajdhevee
Bangkok 10400
Tel: (66) 2644 6000
Fax: (66) 2644 8444
Email: info@nia.co.th
Website: www.nia.or.th
NATIONAL SCIENCE AND TECHNOLOGY
DEVELOPMENT AGENCY
111 Thailand Science Park, Paholyothin Rd.
Pathumthani 12120
Tel: (66) 2564 7000
Fax: (66) 2564 7001-5
Email: info@nstda.or.th
Website: www.nstda.or.th
OFFICE OF SMALL AND MEDIUM ENTERPRISES
PROMOTION (SMEs)
17/F, TST Bldg.
21 Vibhavadi-Rangsit Rd,
Chatuchak
Bangkok 10900
Tel: (66) 2278 8800
Fax: (66) 2273 8850
Email: info@sme.go.th
Website: www.sme.go.th
OFFICE OF THE NATIONAL RESEARCH COUNCIL
OF THAILAND
196 Paholyothin Rd.
Chatuchak
Bangkok 10900
Tel: (66) 2561 2445
Website: www.nrct.net
PHARMACEUTICAL RESEARCH &
MANUFACTURERS ASSOCIATION
21/F, Paholyothin Place Bldg.
408/51, Paholyothin Rd.
Samsen Nai,Phayathai
Bangkok 10400
Tel: (66) 2619 0729-32
Fax: (66) 2619 0728
Email: info@prema.or.th
Website: www.prema.or.th
PROTEIN SOCIETY OF THAILAND
4/F, Rm 427, Chalermprakiat Bldg.
Faculty of Science, Mahidol University
Rama VI Rd.
Bangkok 10400
Tel: (66) 2201 5840
Fax: (66) 2201 5843
Email: proteinthai@gmail.com
Website: http://cbag2.sc.mahidol.ac.th/protein
SERVICE CENTER FOR MEDICINAL PLANT
INFORMATION
447 Sriayudhya Rd.
Ratchathewi
Bangkok 10400
Tel: (66) 2644 8677-91
Fax: (66) 2354 4327
Email: headpypi@mahidol.ac.th
Website: www.medplant.mahidol.ac.th
SHRIMP BIOTECHNOLOGY BUSINESS UNIT (SBBU)
BIOTEC Pilot Plant, Module 2
117 Science Park, Paholyothin Rd.
Pathumthani 12120
Tel: (66) 2564 6531
Fax: (66) 2564 (66)02
Email: info@shrimpbiotec.com
Website: www.shrimpbiotec.com
TECHNOLOGY MANAGEMENT CENTER (TMC)
Pathumthani 12120
Tel: (66) 2564 7000
Fax: (66) 2564 7003
Website: www.nstda.or.th
THAI SOCIETY FOR BIOTECHNOLOGY
73/1 Rama VI Rd.
Ratchthewi
Bangkok 10400
Tel: (66) 2644 8150
Fax: (66) 2644 8150 EXT 406
Email: tsb@biotec.or.th
Website: tsb.biotec.or.th
THAILAND BOARD OF INVESTMENT
555 Vibhavadi-Rangsit Rd.
Chatuchak
Bangkok 10900
Tel: (66) 2537 8111
Fax: (66) 2537 8177
Email: head@boi.go.th
Website: www.boi.go.th
THAILAND CENTER OF EXCELLENCE FOR LIFE
SCIENCES (TCELS)
22/f CMMU Bldg.
69 Vibhavadi-Rangsit Road
Bangkok 10400
Tel: (66) 2644 9524
Fax: (66) 2644 9538
Website: www.tcels.or.th
THAILAND SCIENCE PARK (TSP)
Pathumthani 12120
Tel: (66) 2564 7222
Fax: 66 2564 7201
Email: Tsp-mkt@tmc.nstda.or.th
Website: www.sciencepark.or.th
THE ASIA & PACIFIC SEED ASSOCIATION
7/F Institute of Food Research and Product
Development Bldg.
726, 731, Kasetsart University
Chatuchak
Bangkok 10900
Tel: (66) 2940 5464
Fax: (66) 2940 5467
Email: apsa@apsaseed.com
Website: www.apsaseed.com
THE FEDERATION OF THAI INDUSTRIES
4/F, Zone C
QSNCC, New Ratchadapisek Rd.
Klong Toei
Bangkok 10110
Tel: (66) 2345 1000
Fax: (66) 2345 1296
Email: information@off.fti.or.th
Website: www.fti.or.th
THE GOVERNMENT PHARMACEUTICAL
ORGANIZATION
75/1 Rama VI Rd.
Ratchathewi
Bangkok 10400
Tel: (66) 2354 8857
Fax: (66) 235 9958
Email: intgpo@health2.mogh.go.th
Website: inter.gpo.or.th
THE THAILAND RESEARCH FUND (TRF)
14/F, SM Tower
979/17-21 Paholyothin Rd.
Bangkok 10400
Tel: (66) 2298 0455-75
Fax: (66) 2298 0455
Email: callcenter@trf.or.th
Website: www.trf.or.th

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