Commercialization and role of the private sector

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In general, commercialization of agricultural biotechnology is far behind the application of biotechnology in human health and medicine. In the developed countries, especially in Japan, the private sector plays a major role in the generation, development and commercialization of biotechnology products and techniques. Because of commercial considerations, concentration has been mainly on diagnostics, vaccines, pharmaceuticals and other health-related products. Moreover, because of the eminent involvement of the private sector, marketability of the products and potential return on investment are crucial factors in deciding which products are to be developed and commercialized.

R&D companies in plant biotechnology are still relatively small in Australia, but represent the way in which the R&D infrastructure can be associated with international partners. Particular companies and their fields of interest are:

In Japan, the MAFF is subsidizing fundamental technical development projects in the private sector and providing funds for investment in such projects. It is also offering financial assistance to prefectural governments so as to encourage their R&D activities and utilization of the outcome of such activities. The Ministry takes steps to subsidize the research projects of private technical research associations and other similar study programmes. These subsidies are offered mainly through the Ministry's project for the development of biotechnology and other high technology for the food industry. In fiscal 1989, MAFF began such financial assistance programmes as the "Transformation of plant cells through the introduction of small organelles into the cells" and "Genetically manipulated vaccines against animal protozoa diseases" (Sugishita, 1989).

In the area of biotechnological R&D activities in the food industry, the Ministry started the project "Development of bioreactor systems for the food industry" in 1984. This project has achieved a number of remarkable results regarding the conversion of saccharides, fat and other substances. Another project, the "Development of technology for improvement of enzyme functions for the food industry" aims to improve the functions of enzymes for food production utilizing recombinant DNA technology. In fiscal 1989, the Ministry began a new programme, "Food production by large-scale, high-density fermentation under ultra-high pressure conditions" with a view to increasing the efficiency of the food production process under ultra-high pressures and to finding food materials with a higher value added.

Two more projects were launched in 1989: the "Utilization of extracts from trees (green sprouts project)" and "Advanced and multipurpose utilization of unused marine resources (marine-frontier project)". The objective of these projects is to develop the technique for extracting useful substances from trees and marine organisms and utilizing them for foods, perfumes and medicines, thereby helping further growth of forestry and fishery industries.

The Bio-Oriented Technology Research Advancement Institution (BRAIN) was founded in October 1986 by the joint investment of the government and the private sector. In an effort to encourage the R&D activities of the industries related to agriculture, forestry, fishery and food production, this institution is investing in joint technical development corporations and is providing no interest-bearing loans to the technical research projects of businesses on certain conditions.

During three years from fiscal 1986 to 1988, BRAIN invested in 14 study projects and offered loans to 70 projects. In fiscal 1989, the Institution invested in, among others, the Institute of Aquacultural Technology of Cold Water Fishes, Wakayama Agro-biological Research Centre and the Japan Turf Grass Co. The first is engaged in the development of aquaculture systems of cold water high-class fishes, the second in R&D activities for rationalized process of tangerine juice production and the third in the breeding of better turfs.

In the area of biotechnology-related R&D in the private sector, financing systems through the Japan Development Bank, the Agriculture, Forestry and Fishery Finance Corporation and other similar government organizations were reinforced to turn the results of these R&D activities to practical use. It is hoped that as biotechnology is increasingly introduced to industries, these financial measures will be utilized more in the coming years.

Prefectures are becoming more and more interested in R&D activities on biotechnology and the practical use of the outcome of such activities. This is evident from the fact that almost all prefectures throughout Japan have a council on this technology composed of scholars and other people of expertise.

MAFF is offering to prefectures a variety of subsidies in order to diffuse the mass production technology of virus-free seedlings of vegetables, ornamental plants and fruit trees and the transplanting technology of the embryos of beef cattle. In fiscal 1989, the Ministry started the "Project for establishing embryo supply centres" to ensure a stable supply of embryos of beef cattle. This project is improving the raising and controlling facilities of cattle from which such embryos are taken.

Since 1986, MAFF has also been implementing the "Project for assisting local R&D activities in biotechnology". This project offers financial assistance to the R&D activities of prefectural research institutes concerning the breeding and utilization technology of biological resources. Other biotechnology-related activities of the Ministry include regional biotechnology meetings held in seven locations across the country with the object of exchanging information on R&D. The Ministry's new initiative in fiscal 1989 included surveys and studies for examining the direction of the practical use of biotechnology in each region. The Tsukuba Bioscience Hall created in 1989 provides a forum for collaboration among trainees from industries, universities and the government and international exchange programmes. Furthermore, to foster links among genetic resources and biotechnology, the Ministry has a strong national genebank and germplasm conservation programme (Sugishita, 1989).

Of the developed countries in the region, the involvement of the private sector in biotechnology, especially plant biotechnology, is rather limited in New Zealand. Very little research on plant biotechnology is being carried out by private companies. A shortage of venture capital, low taxation incentives and tough competition from large overseas firms make such ventures unattractive. Several small companies are engaged in either product formulation, or manufacture of biological control agents. Larger international companies (e.g. Monsanto, MPI Koln, PGS Ghent, ICI) and overseas research institutions (UCLA, California; John Innes Institute, United Kingdom; Christian Albrecht University, Germany) have provided personnel, facilities and some supportive funding on collaborative projects. Producer Boards (e.g. New Zealand Kiwifruit Marketing Board) also support research through joint funding of government programmes (Steele and Cooper, 1991).

Many New Zealand research programmes on plant biotechnology are not mature enough to have reached the stage of successful commercialization. In addition, some programmes are commercially sensitive, particularly where research is collaborative with private companies. Examples of plant biotechnology research that have been, or are in the process of being commercialized in New Zealand include (Steele and Cooper, 1991):

Future commercialization is likely to be through the release of improved crop varieties, development of new cultivars and the licensing of technologies that have been developed.

In the developing countries, in vitro culture for micropropagation of elite and disease-free materials, production and distribution of efficient nitrogen-fixing microbes, diagnostic kits and monoclonal antibody-based vaccines are the main areas that have been commercialized to varying degrees in different countries.

In developing countries, the role of the private sector in modern biotechnology has been rather limited. This is attributed partly to (i) vague government policies regarding the private sector; (ii) unclear policies or no policies/views on patents and intellectual property rights; (iii) poor links between public and private sectors; (iv) low purchasing power for new products that are usually highly priced and are out of reach of the majority of resource-poor farmers and low-income consumers; and (v) inadequate local expertise and infrastructure and R&D support to new biotechnology.

In India, biotechnology industries have recently been growing in the private sector. Hindustan Lever Ltd, an Indian subsidiary of the multinational Unilever, the Tata Energy Research Institute (TERI) and Southern Petrochemical Industries are some of the leading biotechnology companies in the country. These have considerable in-house R&D bases active in the application of new technology to agribusiness, such as enzyme technology for high-value chemicals and quality edible oil by using genetically modified bacteria; protoplast fusion in yeast for efficient fermentation and production of edible oil from biomass; tissue culture of plantation and ornamental crops; biological nitrogen fixation; organic components for higher rate of photosynthesis; big-insecticides; plant growth promoters; biomass processing for animal feeds; and hybrid seeds. Some small and medium-size companies are also initiating biotechnology activities but, with less R&D capacity, are more wary of what they consider to be a higher-risk technology.

The private sector in India is particularly active in tissue culture products. There are about 50 private sector companies such as Indo-American Hybrid Seeds, A.V. Thomas and Co., Unicorn Biotek, the three companies mentioned above and others that are comprehensively involved in commercial in vitro production of planting materials of several horticultural and plantation crops such as cardamom, coffee, tea, oilpalm, orchids, strawberry, roses, Spatiphyllum, banana, lily, Gerbera, etc. both for domestic and export markets. These companies have established effective links with the public sector (Kumar, 1990; Prakash, 1993).

The recent liberalization of trade, including that of certified seed, coupled with the greater priority given to science and technology and the promotion of private sector and public-private sector links, should encourage increased participation of the industry in agricultural biotechnology R&D. Financial incentives are available for supporting the growth of indigenous biotech industries. However, venture capital is still lacking. Several multinationals, e.g. Seedtec International, Cargil Inc., Dehlgien Inc., Northrup King and Sandoz (through their local subsidiaries) have been shortlisted by the Indian Government for production of hybrid seeds which may involve biotechnologically produced seeds in collaboration with Indian companies. To take advantage of the availability of expert personnel in biotechnology at relatively low costs, a few multinational companies like Astra AB (Sweden) are setting up a biotechnology R&D centre in India. Recently, Pro-Agro, an Indian seed company, established links with Plant Genetic Systems, a leading Belgium-based plant biotechnology company, for the production and distribution of hybrid seeds.

In Indonesia, there is relatively little direct involvement or sponsorship of research in government institutions at present (Dart, Manwan and Persley, 1991). Some companies are investigating improved planting materials. A commercial production system has been started for improved oil palm plantlets, with a target of 1 million plants per year in 1993, at the Research Institute for Oil Palm at Marihat. Animal vaccines are produced by Pus Vetima and human vaccines by Perum BioFarma, in government-owned companies, which also undertake some biotechnology research.

In the Republic of Korea, the entrepreneurship drive led the biotechnology sector to be organized in 1982 under the Korean Genetic Engineering Research Association (KOGERA). At present more than 20 private companies are participating in this Association. The government provides the members of KOGERA with subsidy as the seed money. In 1980, the public sector provided 70 percent of the R&D support to the biotech industry. Six years later, the situation was reversed; in 1986 the public sector provided only 28 percent of the R&D cost whereas the industry provided 72 percent of the cost. This shows the increasing success and confidence of the private sector. The private companies are mostly involved in fermentation and pharmaceutical matters and have very little interest in agricultural biotechnology. Most of the companies are using biotechnology for the production of antibiotics, insulin, new vaccines and interferons.

The Association performs an important role in the exchange of biotechnology information and also promotes relevant research. MOST provided a special fund for 122 projects in the field of gene manipulation and recombinant DNA technology in 1990. Of these national projects, 32 projects were directly connected with crop improvement (Chung, 1991). The Korean Science Foundation (KSF) has contracted research projects to universities relating to biotechnology in the fields of medical, pharmaceutical, and agricultural sciences.

The entire biotechnology work in agriculture in the Republic of Korea is coordinated by the Agricultural Biotechnology Research Council comprising researchers from national institutes and universities and representatives of industries and the private sector. A few private companies involved in agricultural biotechnology are using the new technology for the production of virus-free potato planting material, and through the anther culture technique are producing haploids for heterosis breeding in Chinese cabbage and rice. The private sector, besides having strengthened its own R&D system, also provides assistance to universities for undertaking specific biotechnological research.

The following tables show the increase in personnel and funds for biotechnological research and development in the private sector in the Republic of Korea.

Table 6
Trend of biotechnological scientists in companies, in the Republic of Korea

Degree 1982 1983 1984 1985 1986 1987 1988
Bachelor 22 29 37 66 84 96 117
Master 35 57 103 111 121 158 189
Ph.D. 7 8 10 14 14 23 23
Total 64 94 150 191 219 277 329

Table 7
Research fund and facility inputs in companies (US$ million) in the Republic of Korea

Item 1982 1983 1984 1985 1986 1987 1988
Project 4.2 6.8 16.6 22.4 22.7 27.4 33.9
Facility 2.9 5.1 10.6 13.2 17.3 21.0 24.5
Total 7.1 11.4 27.2 35.6 40.0 48.4 58.4

It may be seen from Table 6 that the total number of biotechnological scientists in the private companies increased from 64 in 1982 to 329 in 1988. The bulk of the researchers were master degree holders. The number of Ph.D. holders in the private companies more than trebled between 1982 and 1988. Research funding support, as seen in Table 7, increased from about US$7 million in 1982 to US$58 million in 1988 (Chung, 1989).

In Malaysia, R&D in plant biotechnology is also being actively pursued by the large plantation companies such as Guthrie Chemara Research, Golden Hope Plantation Berhad, United Plantation, Eastern Plantation Agency and Sime Darby. These companies have their own research arms and their function is often to serve the requirements and needs of their in-house market.

The activities of the private sector are mainly restricted to those areas that have an almost immediate pay-off, namely in micropropagation. Table 8 lists the plant biotechnology activities of the private sector (Zakri, 1991). Top Plant Laboratories is one of the most successful local companies. It does not depend on its own in-house market, simply because it is not a plantation company like many of the others in Malaysia. It is oriented not only to local demand, but also tries to penetrate the regional and distant foreign markets.

Table 8
Plant biotechnology activities in Malaysia - private sector

Areas of research Plant species Organizations
Micropropagation Oil palm Guthrie, United Plantation, Golden Hope Plantation Berhad
Bananas Eastern Plantation Agency, Top Plant Laboratories
Ornamentals United Plantation, Top Plant Laboratories
Genetic tranformation Oil palm Guthrie
Protoplast culture Oil palm Guthrie

Joint research ventures in plant biotechnology with foreign companies were attempted in the past but failed to take off. An example is the tie-up between Sime Darby and the International Plant Research Institute (IPRI) in California in 1985 with the aim of commercializing tissue culture techniques in tropical plant species. Nothing substantial came out of this joint venture and the deal was terminated. IPRI of course ceased its operations some time before. During initial interest in the clonal propagation of the oil palm, there were also some joint undertakings between local companies with foreign concerns such as Unilever in the United Kingdom, but because of the abnormality problem alluded to earlier, the collaboration was shelved. However, expertise from foreign sources are still being brought in by various companies from time to time to consult on special problems in plant biotechnology.

Regarding commercialization, in January 1991, the National Working Group on Biotechnology convened a round table meeting on commercialization of biotechnology in a developing economy in Kuala Lumpur. The meeting was attended by scientists, entrepreneurs, bankers and business people. Some of the objectives were to review current developments and trends in biotechnology with emphasis towards commercialization; assess the prospects and implications of the biotechnology industries with special reference to a developing country such as Malaysia; identify areas of biotechnology that have potentials for commercialization; create awareness of the potentials of biotechnology industries in Malaysia among policy-makers, entrepreneurs, investors and financiers (Zakri, 1992).

The round-table found that the interest in biotechnology in Malaysia is mostly confined to universities and government research institutions. There is a communication gap between scientists and academicians on the one hand and the commercial sector involving bankers, entrepreneurs and business people on the other. Therefore, as a first step, an information clearing house needed to be established through the initiative of the National Working Group on Biotechnology and based at the Ministry of Science, Technology and the Environment. This unit would function not only as an information dissemination centre but also as a catalyst to encourage better interaction between the researchers and the businessmen. The Government on its part is also encouraging the commercialization of research results by giving tax exemption of five years to approved institutions that are established for the purpose of carrying out research for a particular industry, in this case biotechnology. One of the areas of biotechnology that is deemed to have a head start in commercialization is plant biotechnology by virtue of the long-established interest of the large plantation houses in producing elite propagation materials or cultivars.

An approach considered relevant in producing planting materials on a commercial scale is in vitro technology which encompasses tissue culture and specifically the technique of micropropagation. Potential clones that are envisaged to have immediate commercial impact are oil palm, ornamentals that are native in origin including orchids, and fruits such as papaya, banana and pineapple. Except for oil palm which already has a high internal and in-house market, the ornamentals and fruit clones also need to be tailored for the export market. As a long-term strategy, research on the production of transgenics should also be embarked upon to meet future challenges in this sector.

In Thailand, a large number of private companies have sprung up near Bangkok for in vitro culture and micropropagation of orchids and other cut flowers. The average turnover of these companies is valued at about US$20 million per year. So far there is little R&D in biotechnology related to orchids and cut flowers in the private sector and the link between private and public sector is rather weak. The government recognizes the importance of this link and a Joint Public-Private Sector Coordination Committee chaired by the Prime Minister was established. Furthermore the government has a policy to encourage the increasing role of the private sector in biotechnology and has been providing bank loans, tax incentives and development grants to support such companies. Since food processing industries have been growing annually by 20 percent, and agricultural export is the major source of national income, the Government has been supporting the use of biotechnology for transforming agricultural products into value-added products (Attathom, 1991).

Regulatory aspects

Biosafety

R&D biotechnology is heavily influenced by two regulatory issues, namely biosafety and intellectual property rights. Biosafety aspects include the policies and procedures needed to ensure the environmentally safe development and application of biotechnologies. An effective biosafety system to regulate release and use of Genetically Modified Organisms (GMOs) and to address concerns about potential risks to public health and environment must be in place in all countries involved in biotechnology. Biosafety regulations are necessary also to facilitate technology transfer. Comprehensive biosafety guidelines and measures exist in the developed countries, but the situation is far from satisfactory in most developing countries, although they are aware of the need and are in the process of formulating national frameworks, procedures and capabilities for addressing biosafety issues.

In Australia, biosafety guidelines/regulations have been evolving since 1975, when the Academy of Science Committee on Recombinant DNA (ASCORD) issued its first guidelines. In 1981, as per the Commonwealth resolution, the Recombinant DNA Monitoring Committee (RDMC) was established. In 1987, the RDMC published "Procedures for the Assessment of the Planned Release of Recombinant DNA Organisms". The RDMC was further transformed into the Genetic Manipulation Advisory Committee (GMAC) to include the surveillance of any genetic manipulation procedure resulting in an organism containing foreign DNA that was unlikely to be formed by conventional breeding practices. The GMAC emphasizes that the focus of the assessment should be directed towards ensuring that the release does not cause harm to people, livestock, plants or the natural environment, and not primarily be directed towards considering how the organism was constructed.

GMAC adopted the following procedure (Millis, 1990):

  1. Approval of the concerned Institutional Biosafety Committee (IBC) is obtained.
  2. The IBC sends the proposal to GMAC.
  3. GMAC, according to its Procedures for the Assignment of the Planned Release of Recombinant DNA Organisms, in consultation with its Scientific and Planned Release Committees, analyses and evaluates the proposal, especially the genetic aspects and any possible environmental impact associated with the construct.
  4. The above assessment report, especially pointing out hazards, if any, is sent to the proposer and to the agency that has legal jurisdiction over the release of that particular class of organism.
  5. The responsible agency then makes the decision whether to release or not to release the organism based on the report from GMAC and other related considerations."

In Japan, five guidelines have been established for the regulation of research of DNA organisms and the safe promotion of experiments since 1979 (Figure 1). Appropriate regulations are considered effective in minimizing the potential risks of a new technology to the environment and human health, and in ensuring positive public perception. The purpose of MAFF's "Guidelines for the Application of Recombinant DNA Organisms in Agriculture, Forestry,

Fisheries and the Food Industry and Other Related Industries", is to promote the safe progress of agro-industries by: (i) defining general principles for the appropriate application of rDNA organisms; and (ii) ensuring safety in the use of rDNA organisms (Nakajima, 1991). The guidelines are based on OECD guidelines.

Applications for field trials of rDNA organisms are to be approved by MAFF through biosafety assessments conducted by the authority committee under MAFF. The first application for field tests using transgenic tomato plants harbouring TMV coat protein genes was filed in late 1990. The application was based on three years of greenhouse experimentation. As the biosafety review of this application was completed, the first field trials were approved in 1991 and since then many field tests have been approved.

Figure 1 : Framework for the regulation of rDNA organisms

Research

Ministry of Education, Science Science and Technology Agency
and Culture  

Industrial use

Plant

Microbe

Environmental release

Industrial production process

Simulated model Environment

Open environment

Simulated mod Environment

Open environment

Agricultural chemicals Fertilizers Feed additives Animal drugs Foods Pharmaceuticals Enzymes
Fine chemicals
Ministry of Agriculture, Forestry and Fisheries Ministry of Health and Welfare Ministry of International Trade and Industry

In New Zealand, an Advisory Committee on Novel Genetic Techniques (ACNGT) was set up in 1978 under the terms of a Cabinet resolution. All persons working in the public sector (universities, government departments, etc.) are required to inform ACNGT of their intention to conduct experiments that are defined as "any experiment involving novel genetic techniques that is properly contained and that can be terminated at any point without loss of containment" (Steele and Cooper, 1991).

In 1988 a Genetically Modified Organism Interim Assessment Group (JAG) was established under the Environment Act. The principal role of IAG is to assess all proposals to field test or release GMOs and in so doing provide effective opportunity for public involvement in the assessment process. Private sector researchers are not bound by IAG but are encouraged to use it. In 1989 the New Zealand Government announced that a new agency, the Hazard Control Commission, would be established. This Commission, in addition to responsibilities with respect to hazardous substances, is responsible for assessing and licensing all genetic manipulation work in New Zealand and approving applications to import or release new organisms.

Among the developing countries, comprehensive national biosafety systems/guidelines have been set up in China, India, the Philippines and the Republic of Korea. Most of these guidelines are based on multitier approach, modelled on the lines of OECD and NIH and NAS (United States) biosafety procedures and guidelines for handling and release of GMOs.

In India, the Recombinant DNA Advisory Committee of the Department of Biotechnology (DBT, 1990) prepared a set of Recombinant DNA Safety Guidelines that cover all areas of research and large-scale operations involving genetically engineered organisms, excluding humans. The institutional mechanism for implementing the guidelines consists of:

Environment, to review and approve activities involving the large-scale use of genetically engineered organisms and their products in research and development, industrial production, environmental release, and field applications.

In the Philippines, the National Committee on Biosafety and Biosafety Guidelines is a working group composed of representatives of the Department of Agriculture, the Department of Science and Technology, the University of the Philippines, and the International Rice Research Institute (Padolina and Gapasin, 1991). It has prepared biosafety guidelines that include a provision for case-by-case review of proposed releases of genetically modified organisms. A national Biosafety Committee was established in 1990 to oversee the compliance of policies and guidelines in public and private institutions. A network of 39 Institutional Biosafety Committees was created to ensure the implementation of the guidelines at the institutional level. The National Biosafety Committee coordinates with other national agencies involved in regulations, such as the quarantine services and the environmental management bureau. To date, the National Biosafety Committee has approved 15 applications for the importation of, among other things, transgenic cotton tissue and transgenic strains of rice.

Intellectual property rights

Two Intellectual Property Rights (IPR) mechanisms namely, patents and plant breeders' rights are most important for agricultural biotechnology. A patent is a right granted by the government to inventors to exclude others from imitating, manufacturing, using or selling a specific invention for commercial use during a certain period, usually 17-20 years. The patent holder, in turn, is obliged to disclose the invention to the public. Plant Breeders' Rights (PBR) are rights granted by the government to plant breeders to exclude others from producing or commercializing material of a specific plant variety for a period of about 15 to 20 years.

Both under IPR and PBR, use of the protected matter is restrictive, being highly restrictive under IPR. There is, however, provision for research exemption under IPR which allows others to study the protected subject-matter without reproducing or multiplying it for commercial purposes. Under PBR, there are provisions for breeders' exemption and farmers' privilege. But, in 1991, UPOV tightened PBR by eliminating the breeders' exemption for an essentially derived variety - a variety predominantly derived from another (initial) variety which retains the expression of the essential characteristics from the genotype of the initial variety. Now, as per the 1991 legislation, a breeder who inserts a single new disease-resistance gene into a PBR-protected variety will have to obtain permission from the holder of the original rights before marketing the new variety. In 1991 UPOV also attempted to tighten up farmers' privilege, i.e. freedom to farmers' freedom to use their own harvested material of protected varieties for the next crop on their farm, but because of a lack of consensus among UPOV members it was left to the national governments whether to permit farmers to reuse the seed of a BPR-protected variety for further crop cycles on their own holdings.

The status of development and adoption of IPR and PBR varies widely from country to country in the region. The three developed countries (Australia, Japan and New Zealand) are all members of UPOV and have explicit IPR provisions for biotechnological products and procedures. None of the developing countries are members of UPOV and have mostly been opposed to enforcement of any form of IPR, particularly patents. However, lately, under various kinds of bilateral pressures, such as the special 301 Provisions of the US Omnibus Trade Act of 1988, as well as multilateral pressures, and after having signed the successfully negotiated GATT agreements in December 1993, whether to introduce legislation covering proprietary protection for biotechnology products and procedures, and/or how rigid the protection system should be, are under active debate in several developing countries of the region. Those in favour of having the legislation argue that an effective IPR system would (i) improve the access of the country to new technology from abroad; (ii) stimulate private sectors; and (iii) encourage foreign investment. Those against it argue that in the context of the developing countries it will (i) suppress in-country innovation and local industries and production systems; (ii) increase the dependence on foreign countries even for materials and procedures that are vital for the people of the importing country; (iii) increase prices of even commonly used products and services; and (iv) restrict information flow and knowledge growth. The effects of IPR on the development of biotechnology in developing countries are not clearly understood and should be studied systematically, covering countries at various levels of development and of varying sizes and in the context of different industries, such as pharmaceuticals, agriculture, food industries, environmental protection, etc.

Thailand adopted a new patent act (1992) that protects biotechnology inventions after the United States Government had withdrawn Thailand's trade benefits under the General System of Preferences. Under a similar pressure, when the renewal of the Sino-American Science and Technology Agreement was postponed by the United States Government, China revised its patent law effective as of January 1993, which protects biotechnology inventions, but excludes plant and animal varieties. In India, the matter is hotly debated. Despite the pressure from the United States Government by postponing the Indo-US Vaccine Action Programme and the Indo-US Science and Technology Initiative, the Indian Government has not yet strengthened its IPR legislation. However, given these pressures, the changed and liberated seed policy of the government and increasing pressure from the private seed companies within the country, there is a change in the mood of the government, although strong opposition persists. India signed the GATT agreement in December 1993. Its 1994 Spring Session of the Parliament held a special debate on the issue, and the opposition parties continue to agitate. It appears that a consensus may emerge to evolve an IPR system that will not promote inequity, jobless growth, and ecological degradation. The government is currently preparing an effective sui generis UPOV PBR, explicitly emphasizing breeders' exemption and a strong farmers' privilege. In addition, the system would provide for farmers' rights and include mechanisms for the operation of these rights.

As regards other developing Asian countries with considerable programmes in agricultural biotechnology, no patent protection systems exist either in Malaysia or the Philippines. However, Indonesia is preparing a new IPR legislation.

It can be seen from the above that, under various kinds of pressures, from outside or within, and as biotechnological R&D efforts are being intensified, several developing countries are moving towards restructuring or strengthening their IPR systems. What is important at this stage is that the countries strike a rational balance between the positive and negative aspects of the IPR system and tailor their legislations to their needs, opportunities and aspirations. In countries where the local technology base is weak, an IPR system may contribute little to the indigenous technology capacity. However, if the country is now able to pursue cutting-edge biotechnology and produce innovative and useful products and processes at competitive prices, the relevance of an appropriate IPR would increases. The countries must therefore be able to analyse the various pros and cons and short- and long-term socio-economic and ecoenvironmental advantages and disadvantages of instituting a particular IPR system. International organizations, such as FAO, should assist the countries in this task.


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