Biotec Thailand
Biotec Thailand
1
For distribution at the Consultative Meeting of Asia Cooperation Dialogue in Biotechnology, 6-7 October
2003, New Delhi, India
-1-
Commercial biotechnology is a very research-intensive activity and driven by state-
of-the art and private venture capital. Biotechnology is long dominated by the United States but it has
now grown strongly, particularly in Germany, Britain, Israel and China. U.S. biotech firms total more
than 1,300 compared with about 700 in all Europe. United States federal spending on biotechnology is
US$ 6 billion annually, while many States have additional biotechnology programs.
Canada Government expenditure on biotechnology research and development is estimated to be about
C$ 300 million. An additional C$ 880 million was earmarked for a national genomics work.
Germany has embraced biotechnology as key to its long-term competitiveness. In 1993 the
government passed new legislation designed to streamline decision-making in biotech projects. In
1999, German researchers claimed 14% of all biotech patents applications, up from 10% five years
ago and with more than 400 biotech-related start-ups now. Moreover, the country will channel $175
million over the next three years into a National Genome Research Network to work on the systematic
functional analysis of genes and the use of those research results in the fight against widespread
diseases. The new Genome Research Network involves at least 16 universities, several MaxPlanck
institutes, and four national research centers. The Japanese Government spent US$ 2.5 billion in 1999
on biotechnology, an increase of 12.3% from the previous year. Major funding increases are focused
on new research infrastructure in bioinformatics and genomics and on research commercialisation
initiatives.
Among the developing countries, the India government took the first step in
encouraging a biotechnology industry back in 1986, by establishing a separate government department
charged with increasing the number of biotechnology graduates coming from universities. Fifty
universities now produce about 500 biotech scientists annually. In addition, the government began
funding more than 50 centers around the country to collect genomic data. China is reported to have 24
field tests and 20 commercialized of genetically engineered crops in 1999-2000. Comparing with the
above mentioned countries, biotechnology in Thailand has grown at a lesser extent even though
Thailand has substantial and unique genetic resources of plants, animals and microorganisms.
Biotechnology can bring the enormous benefits and to maintain the competitiveness of Thailand’s
existing agricultural exports. A new era of biotechnology was started when The Thai Government
established the National Center for Genetic Engineering and Biotechnology [BIOTEC] in 1983. Two
years later, two specialized laboratories of BIOTEC, namely Plant Genetic Engineering and Microbial
Genetic Engineering Units were initiated at Kasetsart and Mahidol University, respectively. Now,
modern biotechnology is well developed in most universities and research institutes. The use of gene
technology applications is wider and appreciated in the diagnosis of human and animal diseases. But
the barriers of biotechnology development are adequate and effective funding of public and private
sector research and Thailand’s ability to commercialise its research. Seventeen universities can now
accept up to 600 biotechnology students annually. A survey by the Thai Society for Biotechnology
showed that biotechnology scientists [with Bsc] have worked mainly in food and food beverage
industries and only few with biotechnology industries. Co-ordination of research efforts across
government portfolios is also important. There are no existing mechanisms for such co-ordination
which bring together all portfolios and public funding agencies with a biotechnology interest.
-2-
practical problems. A few specific examples will be given here to highlight the applications of
molecular biology and genetic engineering on agricultural development in Thailand.
Plant transformation
The area of plant transformation should lead to the production of transgenic plants
with superior properties including the resistance to diseases, insect pests and abiotic stress. The Plant
Genetic Engineering Unit [PGEU], the specialized laboratory of BIOTEC at Kasetsart University,
Kamphaengsaen Campus was established in 1985 to carry out the work on plant biotechnology and
genetic engineering. Transgenic tomato plant carrying the coat protein gene of tomato yellow leaf curl
virus was first developed to control the serious virus disease of tomato. The same approach was taken
to develop transgenic papaya and pepper for the resistance to papaya ringspot virus and chilli vein-
banding mottle virus, respectively. Development of transgenic rice varieties has been supported by
the Rice Biotechnology Program launched by the BIOTEC and the Rockefeller Foundation. The
example is transformation of Khaw Dawk Mali 105, an aromatic Thai rice with ∆ pyrroline-5-
carboxylate synthetase [P5CS] for salt and drought tolerance. Most of transgenic plants are now being
tested under greenhouse conditions in accordance with the Biosafety Guidelines. The viral resistance
papaya developed by Department of Agriculture is now undergoing field trial and being
environmentally assessed for possible release.
-3-
Challenges in Product Development using Gene Technology
Thailand similar to other developing countries, needs to form network with other
laboratories to facilitate technology transfer and get accessed to genetic material important in the
construction of genetic modification. The construction of genetically modified organisms is usually
intertwined with license fee and intellectual right obligations. For example, the construction of vitamin
A enriched rice involves more than 70 licenses. Usually the reliance on the expertise of other
collaborators means that strict restrictions are imposed on the use of the products. Capacity building
and human resource development via research is a long-term solution for Thailand to become more
independent in the product development using gene technology. BIOTEC as a research funding
agency, is working actively towards this objective. One notable example is the US$ 3.5 million
funding for the rice functional genomics project. BIOTEC on behalf of Thailand has joined an
International Collaboration for Sequencing the Rice Genome [ICSRG]. This project will form network
with researchers worldwide as well as within the countries. Joining ICSRG will allow Thai Scientists
to directly access the rest of the genome sequence made available by the other collaborating members.
Moreover, BIOTEC hopes to discover several important genes and regulatory elements such as strong
inducible promoters for use to improve the genetic transformation process as well as the genetic
improvement of rice. The project will bring Thailand to international scientific arena, incorporate
state of the art technology and finally improve the competitive edge of Thailand in the international
market.
-4-
The loss from WSSV is international. Equador shrimp production dropped from
144,000 tons in 1998 to 95,000 and 45,000 metric tons in 1999 and 2000, respectively. Due to an out
brake of WSSV in South America, which is a main shrimp exporter to U.S.A., the shrimp production
in Thailand rose to 280,000 metric tons in the year 2000 compared to 243,000 and 230,000 tons in
1998 and 1999, respectively. The example given here serves to illustrate the research invested can
yield substantial returns.
-5-
laboratories to big business, many scientific and technological questions remain. At the same time,
public fears over safety and lack of trust in government and private sector management and regulation
of the new technology have led to widespread concern over GM-food. Anyhow, biotechnology and
gene technology are increasingly becoming part of our world. It is important that people in our
community are made aware of the nature of these technologies and the issues surrounding them. The
single biggest problem is public confidence in science. As such, public awareness program is needed
to inform the public of biotechnology issues, including benefits, risk factors and the measures used to
manage these. It is necessary to consider ways to effectively develop and deliver information to the
public. Several booklets on biotechnology and its application. Including GMOs, cloning and world of
microbes were published by BIOTEC and distributed to schools across the nation. A BIOTEC
Website [http://www.biotec.or.th] on biotechnology provides access to relevant document and
information on latest developments in biotechnology. BIOTEC has also established an electronic
forum on GMOs [http://policy.biotec.or.th] for questions and answers and open discussion. A wide-
ranging public dialogue on hot issues could be pursued by holding meetings in public and posting
minutes to the web. This is one way the government agencies could engage with the public in the
decision-making process. But although everyone has bought into this idea, it will take quite a while to
ensure that this culture change takes hold.
Ethical Issues
The explosion of genetic knowledge comes with some heavy ethical and social
baggage. It is not clear how society will deal with the growing potential to manipulate genomes and
ethical issues bring on dilemma which could not be clearly defined. The U.S. government is grapping
with how to protect individual rights once the technology exists for reading each person’s genome.
Meanwhile, it established an Office for Human Research Protections within the Department of Health
and Human Services. The U.S. government spent about 5% of its human genome project to study the
ethical, social, and legal impacts of genomic research. The German government plans to use US$ 10
million on this issue. Meanwhile, there are attempts from international organizations to set up
guidelines for ethical committee. UNESCO set up International Bioethics Committee (IBC) to set
standards and regulations. World Medical Association announced through Helsinki Declaration on
Ethical Principles for Medical Research Involving Human Subjects. WHO proposed International
Guidelines on Ethical Issues in Medical Genetics and Genetics Services. All of which are
prerequisites for newly developed biotechnology-related guidelines which will potentially be
established in the near future. In Thailand, some guidelines, particularly in genetics, will be initiated
directly by BIOTEC, in co-operation with WHO and UNESCO.
For Thailand, ethical considerations regarding biotechnology are becoming focus,
particularly on advanced biomedical research area. BIOTEC and National Health Foundation are
joining hands on the special project namely “Bioethics and Advanced Biomedical Research”. As some
advanced technologies bring along new frontier confrontation of ethical issues, therefore, specific
technologies are chosen as high-impact ones. These are gene therapy, gene hunting, stem cell research,
genetic testing, human genome database, human cloning and intellectual property on human genetics.
Problems and dilemmas are provoked upon such technologies regarding discrimination, human rights,
eugenics, and rights on one’s own genetic materials. BIOTEC, therefore, initiated Bioethics Advisory
Committee in order to consider, analyse and make recommendations on such special issues. The
committee comprises experts from science, research, medical, religion, law and human rights sectors.
Web site (www.policy.biotec.or.th) and InsightBio newsletter are actively created, updated, produced
and widely distributed among potential stakeholders in order to pass on information and create
awareness throughout Thailand. Moreover, in-dept research and seminars on ethical issues are
continually supported. Public understanding, both directs to public and pass through news agents, is
considered as a significant process to stimulate public understanding. Above all, the reasonable and
acceptable policy on bioethics will be strongly initiated and clearly issued for the sake of Thai society.
-6-
intellectual property rights for new inventions and other progresses in biotechnology have been called
for by the developed countries who dominate this field. Thus far, many developed countries tried to
embody the recognition of biotechnology in various intellectual property regimes, such as the
Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), an agreement under the
umbrella of the World Trade Organization (WTO). Many forms of intellectual property rights, e.g.,
patent, protection of trade secret, and plant variety protection, may be applicable to biotechnology.
With respect to patent protection, developed countries, especially the U.S. tried to
include protections for every kind of living thing, beginning with microorganisms, in the framework of
the WTO, specifically in TRIPS. Developed countries went further, asserting that the existing
intellectual property regimes in most countries should be reformed to include the protection of
biotechnology, and that the new intellectual property rights should be extended to developing
countries like Thailand as well in order that the rights granted will be recognized worldwide. The law
of trade secret may also be a practicable form of protection for particular forms of biotechnology.
When the biotechnology invention cannot be effortlessly reverse engineered the law of trade secret
may be preferable to patent. Trade secret may also be an alternative, if patent protection is not
available for an invention. Today, research and development in biotechnology is believed to be
enhanced with the support of intellectual property rights. New techniques for improving cells
promise to aid in the production of useful substances, whereas intellectual property rights vow to
confer the ultimate benefit on inventors of the said techniques. In the biotechnology industry of many
industrialized countries, scientists use genetic manipulation techniques to modify animal and plant’s
genes and cells to find new hybridizes which are more productive than the parental. These
technologies would succeed in a country like Thailand if they are used with conventional breeding by
providing agricultural services, incentive price policies for agricultural products, and effective
marketing network.
With respect to intellectual property protection, Thailand has enacted several laws
that are applicable for the protection of biotechnological products and processes, e.g., the Patent Act,
the Plant Variety Protection Act, the Bill on the Law of Trade Secret (draft of the Trade Secret Act),
etc. The most used and relevant protection for biotechnology industry is, however, the law of patent
similar to any other existing patent laws worldwide, Thai patents are given to inventions and
processes, which are new, possess an inventive step, and are capable of industrial application. The
protection is given to both product and process of biotechnology. Notwithstanding, patent eligibility is
not given to naturally existing microorganisms and their components, animals, plants or animal and
plant extracts.
Ironically, the law always finds a hard time coping up with technologies. Intellectual
property law is no exception to such matter of fact. As may be seen from this paper that the
advancement of biotechnology in Thailand has moved further into gene technologies, and to genomic
and proteiomic inventions: nevertheless the Thai Patent Act is still struggling with protection for
DNA, genes, and proteins, especially those extracted, isolated, and purified from plants or animals.
This is because the products of which are considered animal or plant extracts that hold no patentability
under the Thai law. The issue of patentable subject matters is indeed not only the question of law but
also the consideration of policy. Patent protection as well as any other intellectual property rights
could be one of the promising tools to confer incentive on biotechnological research and development.
Therefore, Thailand should think through carefully, especially in the post-genomics era, as to what
role would intellectual property rights be playing in order to enhance the progression of the country’s
biotechnology industry so as to scale up the overall economic development and the betterment of
science and technology sector as a whole.
Initially, Thailand should not focus on competing with industrialized countries in
sophisticated biotechnologies, such as gene transfer and genetic engineering. The country should take
advantages of simple biotechnology, for instance, simple technologies of plant tissue, in order to
achieve swift vegetative propagation of valuable crops. There should be an adoption and
improvement of specific plant biotechnology methods that are less expensive, easy to establish, and
appropriate to transfer and adapt to local situations. Moreover, in avoid using sophisticated
technologies developed by industrialized countries, Thailand would be immuned from the intellectual
property right infringement: and, in developing her own technologies, the country would possess
intellectual property rights of her own. This suggestion does not mean that Thailand will not have
access to sophisticated biotechnologies. In fact, biotechnologies vary in complexity and
-7-
sophistication; therefore, they should be distributed to communities by the ability of development
techniques. The national scientific or technological community should be responsible for
sophisticated technologies then adapt them to development projects to serve local needs and keep
abreast of new trends in biotechnology.
Thailand needs to determine her priorities by identifying economic objectives and
considering how to maximize the value of available resources. The government should support
research and development in biotechnology by funding national scientific communities and credit
loans to the private sectors. The government should ensure the transfer of technology to the local
communities in order to enhance techniques of traditional breeding, and increase quality and quantity
of agricultural products.
Conclusion
Modern biotechnology is already making important contributions and poses
significant challenges to agriculture, health and environment. Biotechnologies are a new group of
powerful tools for research and ultimately for accelerating development, and not an end in themselves.
Modern biotechnologies should be used as adjuncts to-and not as substitutes for conventional
technologies in solving problems and that their application should be need driven rather than
technology-driven.
Biotechnology is research based and multidisciplinary. Successful development and
application of biotechnology are possible only when a broad research and knowledge base in several
subjects such as, microbiology, biochemistry, molecular biology and plant breeding exists.
Biotechnological programs must be fully integrated into a research background and a continued
commitment to basic research is a must to fulfill benefits offered by the emerging technologies.
Thailand’s strategy is to keep biotechnology in a balanced perspective by undertaking activities within
the framework of existing national research agendas and priorities.
-8-
Appendix 1: Thailand's GMOs Chronology
Date Events
1983 Inauguration of Thailand's National Center for Genetic Engineering and
Biotechnology (NCGEB, now BIOTEC)
1985 Establishment of BIOTEC's Plant Genetic Engineering Unit (PGEU) in
Nakhornpathom, Thailand
1986 BIOTEC commissioned a status report on the prospects of biotechnology in
agriculture stated the need for the country's biosafety regulatory system
1990 A feasibility study on biosafety by BIOTEC
1990 Biosafety Subcommittee was established under BIOTEC
April 1992 BIOTEC appointed an ad hoc subcommittee to draft Thailand's first biosafety
guidelines
June 1992 Complete draft of biosafety guidelines (for laboratory and for field test)
January 1993 National Biosafety Committee (NBC) established with BIOTEC as secretariat,
followed by establishment of Institutional Biosafety Committees (IBCs) at various
research institutes.
1993 First application for importing transgenic plant for field test on seed production
(Calgene's Flavr Savr tomato)
1994 A list of 40 prohibited transgenic plants added to the 1964 Plant Quarantine Act
1994 Flavr Savr tomato granted permission for field test
1995 Application of Monsanto's Bt cotton.
1995 Establishment of DNA Fingerprinting Unit, BIOTEC in NakhornPathom, Thailand
March 1996 Bt cotton field test experiment started in northeastern Thailand.
1997 Establishment of Plant Biosafety Subcommittee under NBC
1998 Establishment of Food Biosafety Subcommittee under NBC
1998 Establishment of Microbial Biosafety Subcommittee under NBC
1999 Trade dispute between Thailand and some EU countries over detention of tuna in oil
from Thailand. Other trade dispute cases follow suit.
1999 Subcommittee for Policy on Trade of Biotechnology Products set up under the
Committee for International Economic Policy
1999 Amendment of the 1964 Plant Quarantine Act to strengthen regulation of transgenic
plants
September 1999 A report "Status of GMOs in Thailand" published by BIOTEC
September 1999 First public hearing on GMOs organized by Department of Agriculture (DOA) held
in Bangkok
October 1999 First survey in Bangkok by BIOTEC on public awareness and attitude towards
GMOs
December 1999 Inauguration of Thailand Biodiversity Center (TBC) as the potential national focal
point for the Cartagena Protocol on Biosafety (Thailand has not yet signed the
protocol). NBC's secretariat (including subcommittees) moved to TBC.
-9-
Appendix 1.
(continue)
Date Events
2000 Establishment of DNA Technology Laboratory (former part of DNA Fingerprinting
Unit), with a mandate to detect GMOs on service basis, among other tasks.
2000 Establishment of two separate GMOs detection laboratories in Department of
Agriculture and Department of Medical Science
2000 Thailand Food and Drug Administration (FDA) commissioned a work group to
consider labeling method for GM foods
March 2000 Ministry of Agriculture and Cooperatives' declaration on import prohibition of 40
transgenic plants (revised) with exceptions for grains of GM corn and soy bean
April 2000 Trade dispute between Thailand and Kuwait / Saudi Arabia over tuna in oil
(suspected to be made from GM soya bean)
October 2000 A National Subcommittee on Biosafety Policy proposed to the National Committee
on Conservation and Utilization of Biodiversity (NCCUB), with TBC as secretariat
office.
January 2001 Trade dispute between Thailand and Egypt over tuna in oil reached its peak. Both
party agreed to sign MOU.
February 2001 A draft of GMOs policy approved by the Subcommittee for Policy on Trade of
Biotechnology Products
March 2001 BIOTEC starts a series of consultation meeting with stakeholders on GMOs issue
8 April 2002 Minister of Health signed the GMO labeling regulation
10 May 2002 The GMO labeling regulation was noted and became effective
10 May 2003 The GMO labeling regulation is enforced
- 10 -