3 The Global ScenarioThe United Nations Conference on Environment and Development (UNCED) held in Rio de Janeiro in June 1992The Convention on Biological Diversity (CBD) and Cartagena Protocol on Biosafety (CPB) opened for signatureSri Lanka became a party to CBD in 1995 and signed the Cartagena Protocol in 2000 and ratified it on 28 April 2004
4 The Convention on Bio Diversity Identifies biotechnology as a powerful tool for ensuring food security and for alleviating povertyRecognizes the risks of genetically engineered organismsAddresses the issue of biosafety
5 Products of biotechnology are increasingly used to meet the demand for food, shelter and health The commercialization of biotechnology has become a major industry worldwideBiotechnology may have both positive and negative impacts on socio-economic development and environment
6 In Sri Lanka:Traditional Biotechnology – 1970’s ( tissueculture in floriculture)NSF – Special Committee formed in 1992NRC & CARP funding Biotechnology ResearchIn Agriculture - National Agricultural ResearchPolicy for the period , formulated by theMinistry of Agriculture and Livestock, hasidentified biotechnology as a major thrust area inpriority setting and strategic planning in allSectorsBut state patronage has not been significant
7 The need for National Policies on Biotechnology and Biosafety in Sri Lanka
9 A National Policy on Biotechnology In preparationNational Sub-Committee on Biotechnology and Biosafety
10 Vision Towards sustainable development through the safe use of Biotechnology
11 Policy StatementThe development, application and promotion of biotechnology to ensuresustainable progress and socio-economic developmentof Sri Lankawhilst protecting and conservingthe riches of nature
13 Biotechnology has been defined in various ways by international and regional organizations and the global scientific community.FAO, WHOCBDCommission of the European CommunitiesEuropean Federation of BiotechnologyNational Biotechnology Strategy for South Africa of June 2001
14 For the purpose of this policy document, which relates to the Sri Lankan context, Biotechnology is defined as:‘All technologies involving the manipulation of organisms, cells and bio-molecules leading to industrial, agricultural, medical and environmental applications’.
16 Scope of the PolicyThis policy covers all biotechnologies. The coverage includes all aspects of operations related to biotechnology in all sectors.
17 ObjectivesNational Development ObjectivesAn adequate standard of living including adequate food, clothing etc. to its peoplesSustainable development of the economyPoverty alleviationCreation of employment opportunitiesReduction of inequalities in income
18 Biotechnology Policy Objectives The Government’s overall stance on biotechnologyPriority areasCommitment, assistance and support available from the governmentAssigning responsibility for achieving goalsImplementation and risk assessmentPromotion of R&DIdentification of monitoring mechanisms
19 General Principles Ownership Research and development Economic asset and management responsibility of biodiversityPromotion and regulationInternational co-operationPublic awareness and educationSafety and ethical guidelines
20 General Principles…………………(cont.) Import and exportRisk assessment and managementTransparency and information disclosureEquitable sharing of benefitsIntellectual Property Rights (IPR)The formal regulation
21 National Biotechnology Policy Statements recognizing the importance of protecting the country’s biodiversityrecognizing the human and environmental health risksrealizing the need for developing our own capabilities in biotechnology through research and development and trainingreaffirming the commitment to principles of the CBD and CPB,
22 The policy statements are related to: Government Commitment, Planning and ManagementResearch and FundingLegislation including patentingHuman Resource DevelopmentPublic AwarenessIndustrial Applications and TradeInformation Exchange, Monitoring and Evaluation
24 Government Commitment, Planning and Management The government shall make a strong commitment to the sustainable development of biotechnology in Sri Lanka
25 Research and FundingPrioritization of research areas in biotechnology shall be carried out based on the national development policy and with the concurrence of public and private S&T institutions and agencies responsible for such fields of activity (eg. Universities and National R&D Institutions)
26 Research and FundingAppropriate institutions and centres that are currently involved in biotechnology research and development, shall be assisted to evolve as Centers of Excellence in different aspects of Biotechnology. Such Centers shall be networked to provide stronger rapport between the government, the public and the scientific community
27 Research and FundingA funding mechanism shall be devised to support R&D and all other aspects of biotechnology. Co-ordination of research projects and transfer of skills and expertise shall be facilitated in order to increase the possibilities of using and monitoring the technology.
28 LegislationLegislature shall be introduced to cover biotechnology applications and all related issues regarding human beings (eg. diagnosis, gene therapy, cloning and ethical assessment of research applications, etc).
29 Human Resource Development Priorities in Human Resource Development in biotechnology shall be assessed and identified
30 Human Resource Development S&T and management of biotechnology shall be developed and maintained at a high level by providing training, conducive environment for R&D, and incentives and rewards to attract and retain scientists and trained personnel.
31 Human Resource Development Teaching of biotechnology shall be strengthened, both at secondary and tertiary levels, and continued professional development of teachers shall be facilitated.
32 Human Resource Development Special courses in natural sciences, technology and ethics at academic level shall be offered to personnel, who in their professional activities come into contact with biotechnology issues and their ethical applications.
33 Public AwarenessPublic awareness of biotechnology and potential risks/benefits, risk assessment and management techniques shall be enhanced, involving the community at large, policy makers, legislators, administrators, the private sector and biotechnology industries.
34 Industrial Applications and Trade Safety standards shall be reviewed and updated at appropriate intervals to incorporate local and global changes in technology.
35 Industrial Applications and Trade Mechanisms shall be identified to actively promote and facilitate transfer of research findings to industrial and other applications.
36 Industrial Applications and Trade All Biotechnology units undertaking commercial production shall be treated as industry and would thus be eligible for all incentives to which industries are eligible.
37 Industrial Applications and Trade The importation of biotechnology products shall be according to the National Biosafety Regulations.
38 Industrial Applications and Trade Sri Lanka shall endeavor to implement local field trials of imported products or procedures to the extent of its ability, financed by the applicant, where existing data are regarded as inapplicable under local circumstances.
39 Information Exchange, Monitoring and Evaluation Appropriate knowledge bases and infrastructure for information exchange shall be established and developed.
40 Information Exchange, Monitoring and Evaluation The development and use of biotechnology shall be promoted for the continued welfare and socio-economic upliftment of the nation, while addressing the issues of biological safety, which may affect biodiversity of plants, animals, microorganisms, human health and environment.
41 Information Exchange, Monitoring and Evaluation Priority shall be given to the establishment of an efficient research management system and the development of research infrastructure such as biotechnology information centers, biotech parks and other institutions involved in research, design, consultancy and information, in order to strengthen the facilities for the smooth transfer of technology and development of new products.
42 Information Exchange, Monitoring and Evaluation A Master Plan for Biotechnology shall be established and used to implement the strategies and to develop the infrastructure and instruments outlined in this policy.
43 Commitment of the Government of Sri Lanka Support by way of financial & at policy levelLegislation & regulationFunctional body for BioethicsPatents ActHRDPublic awareness