ASEAN Agro-Biotechnology: Overview and Recommendation on Regional Collaboration Sakarindr Bhumiratana and Ruud Valyasevi
Established August 8, 1967 in Bangkok (I, M, P, S, T) • Brunei - ‘84, • Vietnam -‘95, • Laos and Myanmar – ‘97, • Cambodia – ‘99. • Population ~ 500 million • Area ~ 4.5 million sqkm • GDP ~ US$737 billion, • Total trade ~ US$ 720 billion. • Primarily agriculture based. The Importance of Agriculture:
ASEAN - AgBiotechnology • Have invested much in the development of R&D, human resources, and infrastructure support for biotechnology. • Many challenges, issues and concerns • Strategies are to keep biotechnology in a balanced perspective in the framework of existing national research agendas and priorities. • Plant transformation, Marker assisted selection (RAPD, QTLs..) • Plants and animals
Status of Ag-Biotechnology applications in ASEAN: • Few have clearly approved the use of GM food crops as human and animal feed, • All have imported products such as GM-soy, GM-maize and processed food-products
GM Crop production • Indonesia allowed limited (spatial and time) production of Bt-Cotton. • Indonesia, Malaysia, Philippines, Singapore, Thailand and Vietnam have conducted limited GMO field trials
GM Crop production Crops (being) tested are Bt corn, Bt soybean, Roundup Ready Soy, Bt Cotton, Flavor Saver Tomato, Viral resistant papaya and tomato; from local & Monsanto, AgroEvo, Pioneer Seeds, Cargill Seeds, and Novartis. • Some cases where requests for field trails were turned down. • No report of field trials in Brunei Darussalam, Cambodia, Laos or Myanmar.
Clear Policy ?? • Singapore ~ Asia Center on Health related Bio-industry. Add 7,000 biotech researchers, invest + $ 2.5 billion by 2005. • Japan + 1,000 new biotech comp with $217 billion investment by 2010 • China to double its 3,000 biotechnology research centers in 10-15 years. • Malaysia - “Bio-valley” plan, $12 billion in 10 years. National Biotechnology Directorate to spearhead • Philippines - biotechnology programs in 1979 National Institutes (BIOTECH) +3 biotech inst in’95. (PhilRice). • Thailand’s BIOTEC of NSTDA. - Science Park.
ASEAN development in biosafety • Indonesia has clearly stated regulations, but has some difficulties implement them. • Malaysia has drafted a biosafety bill and is in the process of having it legislated into law. • Indonesia and Singapore had developed guidelines for labeling of GMO products. • ASEAN have developed env-safety guidelines; except for Brunei, Laos, Myanmar and Vietnam. • Based mainly from UNEP, UNIDO, CBD, MAFF, UK, GMAC and FAO guidelines • To adopt the product-based rather than process-based approach for the evaluation of GMOs. • Substantial equivalence - case-by-case basis.
Regulatory Policy and Institutional Framework in ASEAN • Indonesia, Malaysia, Philippines and Thailand, have successfully conducted field trials of GMOs. • Indonesia is the only country which has approved the environmental release of Bt cotton. (7 districts in South Sulawesi province), the cotton seeds are to be exported only and the remaining plant parts must be destroyed. Annual renewal. • Indonesia - completed field trials for soybean and corn
Regulatory Policy and Institutional Framework in ASEAN • Thailand - concluded three years of environmental studies on Bt cotton, corn, tomato; viral resistance papaya is being field studied. • Malaysia - concluded the env-assessment of GM soy • Philippines - completed field trial of Bt corn • Singapore - approved commercial sale of GM blue cut carnation but not for growing. • There have been reports of illegal planting of GM crops, particularly Bt cotton by farmers in Thailand, Vietnam and Indonesia.
Policy to be developed: • Cambodia, Laos, Myanmar, Brunei and Vietnam. • Laos is setting up the National Biosafety Framework, designated STEA as national focal point. • Brunei is establishing a National Authority on Genetic Modification (NAGM) to oversee the regulatory control of GMOs. • Vietnam has formed a working group and drafted the Biosafety Bill which is being approved by the Ministry of Science, Technology and Environment.
Exercised some regulations: • Malaysia and Thailand - expect biosafety legislation in ‘02. • Philippines - Biosafety Guidelines published in 1991. • Indonesia - provisions on biosafety of genetically engineered agricultural biotechnology products released under the Ministerial Decree No. 85/kpts/HK 330/9/1997. The Decree of the Minister of Agriculture does not have law enforcement power. Furthermore, there is Law No. 5/1994 for the Ratification of the UN Convention on Biological Diversity and Law No. 7/1996 on food. • Singapore - guidelines for “Release of GMOs used in Agriculture”- use of Acts administered by the Agri-Food and Veterinary Authority of Singapore (AVA)
Existing legislation in ASEAN; • Generally uses the sanitary and phytosanitary requirements, and Acts enacted in these areas, to regulate importation of GMOs. • e.g., Plant Quarantine Act, Animal Control Act and Fisheries Act, Food Act and Hazardous Substance Act.
Access to GMOs by small farmers • Region of small farmers who cultivate areas of less than 1 hectare. • Many of them are resource poor / subsistence - products developed to suit their particular needs? • Issue and concern on the use of traditional knowledge and biodiversity. • TRIPs - no specific provisions related to the protection of traditional/indigenous knowledge (systems, practices, naturally-occurring plants, products)
Policy Recommendations for ASEAN • Most urgent need -- building local & regional capacity, • Human resource is the key to this development • Transferring of technology and skilled scientists can help speed up the process, but technology imbedded in the products will do little in strengthening the capabilities. • Major hindrance is Political View and weak management infrastructure • IPR and biosafety systems.
Human Resource Development: • Capability to pursue high priority biotechnology research - Training of scientific and technical manpower is a crucial element • A national effort with strong supportive input provided by mutual co-operation within the region and international agencies • ASEAN-help-ASEAN can be coordinated through the functional committees and other ASEAN mechanisms. • Resources must be made available to facilitate the flow of people across national boundaries for the training and collaborative S&T activities • VUST
S&T Policy, Planning and Organizational Structure • Biotechnology research requires sophisticated infrastructure, including identification of appropriate areas, strong management and funding system, and appropriately equipped research facilities. • S&T infrastructure is complex and in most of the region requires a subtle cultural change. Such processes take time and perseverance. • Regional collaboration can be an excellent tool to help push members over the hurdle and the resistance to change. High-level Heads of State, Ministerial, and Senior Official Meetings can help to pursue the much needed political support.
S&T Policy, Planning and Organizational Structure • Fostering supporting management mechanisms, excellence and competitive research will evolve to generate innovation. • To attach due importance to the development of locally and regional needs. • Providing incentives for R&D (tax regimes, venture capital tax incentives, other) • ASEAN must work within ASEAN to foster the linking of the excellent/specialized centers, forming networks, combining to build strengths and combining strengths to work on regional issues of importance.
S&T Policy, Planning and Organizational Structure • The linking of excellent/specialized centers or any other agencies requires commitment in cost sharing and making travel and meeting/workshop costs available. • Funding has been difficult, but more difficult has been the priority accorded to regional commitment.
Some specific areas on risk issue: • Policy and decision making process. • Developing legal framework for biosafety • Training in and implementing risk assessment • Development on data management and info sharing • Upgrade technology and preparedness to implement a biosafety regulatory framework. • Developing biosafety clearing house mechanism which should facilitate cooperation amongst ASEAN.
Information Exchange, Regulatory and Harmonization: • Information exchange better understanding, more active interactions, stronger region, • AFTA -- Standards and regulations need to be harmonized to reduce any possible friction and ensure fair practice. • Building communication and information access and exchange -Critical to the success of a harmonization process • Technology transfer information network
Information Exchange, Regulatory and Harmonization: • Misinformation and the lack of scientific understanding can lead to poor judgment, mismanagement and missed opportunities. • ASEAN must work together to increase public awareness and understanding of S&T, and particularly, biotechnology. Ensuring public awareness at all levels. Prep of documentation and information packages
Intellectual Property Rights: • Role of intellectual property rights in enhancing the progression of the region’s biotechnology capabilities. • Cultural and traditional practices are being tested and put under various constraints due to globalization forces. ASEAN needs to work together to make the requisite change as painlessly as possible.
Intellectual Property Rights: • On biodiversity, ASEAN countries should come together to develop national legislation on protection of indigenous and/or traditional knowledge and on that basis formulate an ASEAN collective position to be advocated at international level. • Countries should develop an inventory and registry of their biological resources and traditional/indigenous knowledge, taking into account the intellectual property implications of such inventories and registries. • There should be a network of information exchange and networking among the ASEAN member countries for this purpose.
Intellectual Property Rights: • There should be a network of information exchange and networking among the ASEAN member countries for this purpose. • Working with Integrated IP Escrow Service (Patent Pool) • Provide tech owners, the public sector and the small business community with a convenient and trusted service