Debates on science and technology policies of Thailand are usually the domain of a small group of scientists and technocrats. Discussions on biotechnology policy, on the other hand, can count on the attention of various groups in society. They have been partly successful in counteracting political pressure from the US government and Thai export business to accept a one­sided strengthening of intellectual property protection. However, the public involvement in biosafety regulation is lacking.

The first proposal for a patent law, in 1965, was rejected by the Thai parliament. The parliament was afraid that it would obstruct the industrial development of Thailand, laid down in the First National Social and Economic Plan formulated in 1959 under the auspices of the World Bank. Thailand's first patent act was only approved in 1979 by the military government. This Patent Act of 1979, however, does not protect biotechnological matters, stating that "no patents will be granted for invention initiated from food, beverages, pharmaceutical products or ingredients, any variety of animals or plants or any essential biological process for the production of animals or plants etc".
During the 1980s, following the US economic crisis, the US government made an attempt to alter the Patent Act to allow protection of biotechnological substances. This attempt was related to US concern about intellectual property rights (IPRs) violations in Asia. The US government threatened Thailand that if it would not respond positively, the USA would retaliate by cutting trade privileges through the General System of Preferences (GSP) and the Special 301 under the Omnibus Trade and Competitiveness Act of 1988. At the same time, action was undertaken by medical associations and unions, both in Thailand and in the USA, to encourage Thailand to modify the Patent Act of 1979 to protect medicine, biotechnology, and machines used in agriculture including computer software.
The US position activated various groups in Thailand such as academic groups, NGOs, traditional medicine producers, university and college students, and a number of politicians. These groups aimed at preventing the Thai parliament from amending the law, as demanded by the USA. In their opinion, the advantages of the trade privileges could not outweigh the impact of patents on food and medicine. Patents on medicines were expected to increase their price. Moreover, granting patents on biotechnological processes would enable patents for all life forms: plants, animals and micro­organisms.
Despite these public concerns, the Patent Act of 1979 was modified in 1992. The decision was made solely with the interests of the export business in mind, that wanted to keep the trade privileges granted by the USA. The Patent Act of 1992 states that "it is prohibited to patent micro­organisms or any elements related to micro­organisms from natural resources or animals, plants or any substance extracted from animals or plants". Pharmaceutical products and essential biological processes for the production of animals, plants, and micro­organisms are no longer exempted from patenting. Currently the USA is exercising further influence on Thailand to allow for the patenting of plants, animals, and micro­organisms.

Plant variety protection
As a result of the Green Revolution, Thai agriculture has changed from traditional into modern input­intensive farming. About 80 per cent of the farmers have become dependent on new varieties, fertilizers and pesticides. 90 per cent of the vegetable seeds, more than 50 per cent of the field crop seeds and almost 100 per cent of chemical inputs are imported. This gives multinational companies a tremendous influence on Thai agriculture.
The lobby of a number of multinational companies and Thai breeders to issue the Plant Variety Protection Act (PVPA) has resulted in the drafting of two new bills, one by the Ministry of Agriculture and Cooperatives, the other by the Ministry of Commerce. The contents of the two bills are similar. The difference is that depending of which law will be accepted, plant variety protection will be the competence of either the ministry of commerce or the ministry of agriculture. The main purpose of the Thai PVPA is to protect exclusive rights for new plant varieties. For example, the bill proposed by the Ministry of Commerce has identified 44 plant species to be protected. Among them are principle Thai export crops such as rice, maize, orchids, rubber, and wheat.
The two bills have faced opposition from some Thai breeders and farmers' groups which disagree on certain points in the bills. They want a farmers' privilege, farmers' rights and protection of traditional plant varieties to be included in the law. More importantly, there are no provisions for benefit sharing included.
To solve the conflict, the government has appointed the Committee for Plant Variety Protection Bill Drafting. This Committee, which includes farmers, has combined the two bills into one single bill. The new drafted bill follows the sui generis option as stated in Act 27.3(b) of the Trade Related Aspects of Intellectual Property Rights (TRIPs) under aegis of the General Agreement on Tariffs and Trade (GATT), thereby allowing for the possibility of including farmers' privilege. The purpose of the bill is to protect native plant varieties, although usually plant variety protection is to protect new varieties. The bill is presently under review by the Committee, and is expected to be ready this year.

The challenge of sui generis
In June 1997, Thai and English newspapers reported on the interference of the USA against the protection and promotion of Thai traditional medicine, as proposed by the Ministry of Public Health. The Traditional Medicine Bill covers three areas: (a) the principle that traditional medicine can be accessed and used; (b) the registration of traditional medicine practitioners; and (c) the establishment of an authoritative institution.
TRIPs allows for the protection of plant varieties either by patents, by an effective sui generis system, or by any combination thereof. In other words, member countries have the option of developing an effective sui generis system for protecting plant varieties as an alternative to patents. At present, Thailand has no law to protect indigenous knowledge and products, particularly from herbal plants. Therefore, by including this issue, this omission will be fulfilled.
A US governmental letter to the Thai Department of Intellectual Property stated that the USA learned about the bill in progress that would allow Thai healers to register traditional medicines to claim benefits before Thailand ratifies the United Nations Convention on Biological Diversity. The USA claims that the proposed registration system constitutes a violation of TRIPs. Their main concern is that this bill obliges US and other companies or researchers who want to make use of Thai traditional knowledge to ask for permission from the owners of the knowledge. However, it is not for the USA to judge whether this bill violates TRIPs  but the World Trade Organization (WTO), the successor of the GATT. In the meantime, reacting to the US interference, not only Thai academics, lawyers, NGOs, the Network on Traditional Knowledge and Community Rights in Thailand, but also more than 100 organizations and institutes from all over the world have sent letters of protest to Madeleine Albright, the Secretary of State of the USA, to which she has not yet responded.
Recently, the bill to protect and promote Thai traditional medicine has been approved by the cabinet and is being amended before being proposed to parliament to be issued as an act. This act will present the new trend of IPRs in countries such as Thailand. Increasingly countries will use the sui generis possibility, against the wishes of the USA, to adapt an IPR system to local needs. In 1999, the TRIPs will be reviewed at the WTO meeting.
The Traditional Knowledge and Community Rights Bill has already been adopted to protect the rights of owners of traditional knowledge. Although with some similarities to the PVPA, this is an independent bill, which acknowledges traditional knowledge in benefit sharing.

Biosafety regulations
Biosafety has received far less attention in Thailand than the issue of IPRs. Thailand has no specific laws on biosafety yet. Instead, some related acts are applied. The acts that regulate biotechnology products are the Plant Quarantine Act of 1964 and the Plant Variety Act of 1975, which regulate import and export of plant varieties. Both are applied to transgenic plants. The Animal Disease Control Act of 1962 and the Animal Pathogen and Toxin Act of 1982 are enforced for animal vaccines, toxins and transgenic animals. The Hazardous Substance Act of 1992 and the Fertilizer Act of 1975 are applied for
r­DNA derived biotechnology products. Additionally, the Enhancement and Conservation of National Environmental Quality Act of 1992 relates to environmental protection areas.
At the policy level, the Ad Hoc Biosafety Sub­Committee, set up in 1992, is a main unit which selects the safety system for biotechnology including genetic engineering both at the laboratory and field levels. The National Biosafety Committee, established in 1993, plays an important role in the field of biosafety in Thailand. It is currently working on launching biosafety­related policies in cooperation with various other organizations and with the private sector. The Committee has developed guidelines that direct the work of scientists, project supervisors and administrators in conducting genetic engineering research. Since 1993 the Center for Genetic Engineering and Biotechnology has served as a secretariat office to operate the guidelines. However, since the guidelines are not considered as law, they cannot be enforced. It is up to the politicians to decide to transform these guidelines into legal acts.

Field trials
Currently, no public debate is taking place on biosafety, and no public citizen's groups are involved. This situation might change when the activities related to genetically modified organisms (GMOs) and research work on r­DNA technology increase. Already applications for field trials with GMOs in Thailand have been submitted. A few examples are:

• the development of a recombinant vaccine protective against the causative agent of a poultry disease avian colisepticemia by the Tel­Aviv University (Israel) and the Chulalongkorn University (Thailand), in June 1991;
• the evaluation of a male sterility system for hybrid maize, by Plant Genetic Systems, Belgium, in August 1992;
• the production of virus­resistant seeds of genetically engineered cantaloupe and squash, by Asgrow Seed/Upjohn, USA in September 1992.
• genetically modified tomato plants with altered ripening characteristics to produce quality seed for future large scale trials, probably in the USA. The company responsible for the March 1993 trial was Zeneca Seed, UK.

A project that attracts attention, and is currently under field trial, is the one on Bacillus thuringiensis (Bt) transgenic cotton, conducted by Monsanto, USA. The contained trials in Thailand were initiated in 1996, and expanded to field trials. It was mentioned during the meeting of the committee in charge of the field experiments that during the contained trials about 40 per cent of the bees, which are beneficial insects, died. It is difficult to judge this warning sound since the results of the experiments have still not been revealed to the public yet. There is no information available on the effects on other kinds of beneficial insects. It is noteworthy that there are representatives from Monsanto Company (Thailand) in the committee on Bt transgenic cotton. If the experiment is successful, Monsanto's subsidiary in Thailand also plans to import other kinds of plants similar to Bt transgenic cotton, such as Bt transgenic maize and Bt transgenic yellow bean, without asking for permission according to the Plant Quarantine Act of 1964 and biosafety guidelines issued by the National Biosafety Committee of Thailand. This import would thus be a violation of the 1964 Plant Quarantine Act which prohibits the import of any (transgenic) plant variety without the permission of the Ministry of Agriculture.
Jaroen Compeerapap

Lecturer of Law, Faculty of Law, Chulalongkorn University, Phyathai Road, Bangkok 10330, Thailand. Phone (+66) 2 2182039; Fax (+66)
2 2182018; E­mail wongwai@wnet.net.th

Source
Banpot Napompeth (1996), Development and Implementation of Biosafety Regulations in Thailand. Paper presented at the International Workshop to Follow­up on UNEP's International Technical Guidelines for Safety in Biotechnology, October 31 ­ November 1, 1996. Buenos Aires: Argentine.