Treaties and Conventions Related to Management of Genetic Resources

Transcription

1 Treaties and Conventions that Govern Exchange of Genomic Resources Treaties and Conventions Related to Management of Genetic Resources Pratibha Brahmi, PGR Policy Unit NBPGR

2 How we define terms (context and scope) Biodiversity: The variability among living organisms from all sources; diversity within species, between species and of ecosystems. (The Biological Diversity Act 2002) Biological resources includes genetic resources, organisms or parts thereof, populations, or any other biotic component of ecosystems with actual or potential use or value for humanity (CBD) Biological resources: Plants, animals and microorganisms or parts thereof, their genetic material and byproducts (excl. value added products) with actual or potential value or use, does not include human genetic material (The Biological Diversity Act 2002) Genetic material: means any material of plant, animal, microbial or other origin containing functional units of heredity. (CBD) Genetic resources: means genetic material of actual or potential value. (CBD) Gene: A section of DNA which contains information for making one protein molecule; a unit of hereditary information that can be passed from one generation to another. (Source: IUCN) Germplasm: The economic, scientific or societal value of heritable material contained within and among species. (Source: Bioversity International) Agro-biodiversity: Component of biological diversity of interest to food and agriculture. (Source: Bioversity International) Genomic Resources???

3 (Relevant Indian Legislation) Convention on Biological Diversity (CBD) (Biological Diversity Act 2002) Scope/ Applicability Covers all biodiversity related issues. Provide general principles for access and benefit-sharing concerning materials collected after the coming of CBD and not covered by the International Treaty on PGRFA. Status/ Jurisdiction Legally binding for countries that have ratified (187 as on December 2010). Ratifying countries must adopt appropriate legislation/ regulations and/ or bring existing ones into harmony with the Convention.

4 (Relevant Indian Legislation) CBD/ International Protocol on Biosafety (Cartagena Protocol) (Guidelines for safety of Biotechnology by DBT, 2002 under the Environment Protection Act (EPA) 1986) Scope/ Applicability Provides international regulatory framework for trade and protection of environment from adverse effects of products of modern biotechnology. Status/ Jurisdiction Adopted in January, 2000.

5 Scope/ Applicability Status/ Jurisdiction International regime on access and benefit sharing (Nagoya Protocol on ABS) Internationally recognized framework for fair and equitable sharing of benefits arising from utilization of genetic resources through designated check points and ensures compliance with mutually agreed terms. Binding for all parties Adopted during 10 th CoP of CBD at Nagoya Japan in October, Open for signatures by contracting parties from 2 rd Feb, 2011 to 1 st Feb, 2012.

6 (Relevant Indian Legislation) International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) Scope/ Applicability Covers all PGRFA (does not regulate non-food and nonagricultural uses) and addresses diverse topics, including conservation, use, international cooperation, technical assistance and farmer s rights. Establishes multilateral system (MLS) for selected crops (over 35 food crops/29 forages species). Sets rules for access and benefit-sharing for these materials, both ex situ and in situ, while respecting property rights. Status/ Jurisdiction Adopted by FAO Conference in Entry into force after the 40 th country ratified in November Legally binding for all countries that ratify and not applicable to those that do not. Countries that ratify will be required to bring national laws and regulations into conformity with the Treaty. CGIAR Centres have signed agreements with the Treaty s Governing Body in order to adhere to the Treaty formally, and put all the material available with them under the MLS.

7 (Relevant Indian Legislations) WTO- TRIPS Agreement (Protection of Plant Varieties and Farmer Rights Act 2001, Patent (Amendments) Act 2005, Geographical Indications of Goods (Registration and protection) Act 1999) Scope/ Applicability Members States must comply with minimum standards of protection of IP. Must ensure protection of microorganisms, non-biological and microbiological processes and plant varieties that meet protection criteria. Status/ Jurisdiction Entered into force in January, 1995 after the Marrakesh Ministerial Meeting in April, Legally binding on all WTO Members. Has Possibility for trade sanctions for those found not in compliance.

8 (Relevant Indian Legislation) WTO/ Agreement on Application of Sanitary and Phytosanitary Measures (Plant Quarantine (Regulation of Import into India) Order 2003 and its amendments issued under the DIP Act, 1914) Scope/ Applicability Covers measures adopted by countries to protect human or animal life from food- borne risks; animal or plant- carried diseases; plant pests and diseases to ensure food safety and prevent the spread of pests among animals and plants. Status/ Jurisdiction Adopted by 153 WTO members presently.

9 (Relevant Indian Legislation) International Plant Protection Convention Plant Quarantine (Regulation of Import into India) order 2003 and its amendments issued under the Destructive Insects and Pests (DIP) Act 1914 Seed Bill (2010) Scope/ Applicability An instrument and forum for harmonizing phytosanitary measures used in regulating international exchange of plants and planting material Status/ Jurisdiction Established in 1952 (last revised in 1997).

10 Union for Protection of Plant Varieties (UPOV), (India is not a member of UPOV) Scope/ Applicability UPOV aims to maximize plant breeding efforts by providing a model for securing protection under UPOV for plant breeders rights for plant varieties. Status/ Jurisdiction Four versions; only 1991 is still open for joining. Legally binding on Parties

11 FAO Global Plan of Action Scope/ Applicability Covers all PGRFA. Contains specific activities on in situ conservation and development, ex situ conservation, utilization and institutions and capacity building. Status/ Jurisdiction Adopted in 1996 by the 4 th International Technical Conference on PGRFA (150 countries). Legally non-binding. Serves as a framework, guide and catalyst for PGRFA, and thus has a bearing on and a relation to a legally binding agreement.

12 FAO Code of Conduct for Plant Germplasm Collecting and Transfer Scope/ Applicability Deals with the etiquette of collecting and transfer of PGRFA. Has a provision on collector s permits, responsibilities of collectors, sponsors, curators and users, as well as on reporting, monitoring and evaluation observance of the code. Status/ Jurisdiction Adopted by FAO Conference in Not legally binding.

13 FAO-CGIAR Agreements Placing collections under the auspices of FAO, Scope/ Applicability Agreements apply to the management, availability and transfer of specifically designated germplasm. Status/ Jurisdiction 12 Centres (those having ex situ collections) had signed binding agreements with FAO.

14 National Legislations with Implications on Access to Plant Genetic Resources

15 Acts/ Guidelines Objectives Scope Protection of Plant Varieties and Farmer Rights (PPVFR Act, 2001) effective from: January, 2005 To provide for an effective system of protection of plant varieties; and rights of farmers and plant breeding; ensure availability of high quality seeds improved varieties to farmers. New varieties to be protected (registered) in the Act, should be novel, distinct, stable and uniform (NDUS), and shall be subjected to tests by the PPVFR Authority. Application for new varieties should be accompanied with complete passport data of all the genetic resources used in the development of new material. Proof of lawful acquisition of all materials used in development of new varieties to be furnished.

16 Acts/ Guidelines Objectives Implications for Gen. Reso Biological Diversity Act effective from: April, 2004 Conservation and sustainable use of biological diversity; regulation of access to biological resources; secure sharing of benefits out of use of Indian biological resources/ use of traditional knowledge The access to Indian biological resources by non- Indians shall be subject to the approval of National Biodiversity Authority These conditions do not apply to transfer of genetic resources under any collaborative project approved by the Govt. of India, and also transfer of results under approved projects.

17 Acts/ Guidelines Objectives Implications for Gen. Reso. Patent (Amendments) Act 2005 effective from: January, 2005 New amendment include patenting on newly developed (GM) microorganisms and micro biological process that conform to the criteria of novelty, inventive step and utility Source of biological resources used in the development of patents is to be acknowledged. All biological resources used in development of patents to be deposited in the designated repositories before sealing of patents.

18 Acts/ Guidelines Objectives Scope Geographical Indications of Goods (Registration and Protection) Act 1999 Applicable to goods such as agricultural goods, natural goods or manufactured goods as originating and manufactured in a territory of a country where the given quality/ reputation is essentially attributable its geographic region (Land races of crop specific to certain agroclimatic regions of the country with attributable quality and reputation). Agricultural products granted GI e.g. a. Darjeeling tea, b. Malabar cardamom, c. Hill banana of Karnataka d. Malihabadi mango

19 Acts/ Guidelines Objectives Scope Plant Quarantine (Regulation of Import into India) Order 2003 and its amendments under the DIP Act, 1914 effective from: April, 2004 Rules for Regulating the Import of Plants etc. into India, including import of germplasm/ genetically modified organisms (GMOs)/ transgenic planting material; live insects/ fungi including biocontrol agents, soil, timber and wooden logs. The order includes Prohibition on import of commodities with weed/ alien species contamination Restriction on import of packaging material of plant origin unless treated. Additional Declarations to be given on phytosanitary certificates specified and notified points of entry have been increased to 130.

20 Acts/ Guidelines Objectives Scope Guidelines for Safety of Biotechnology by DBT under the EPA 1986 effective from: 1990 (last revised in 1998) National framework for development of genetically modified plants and their commercial exploitation. Gives guidelines for import and shipment of genetically modified plants only and for toxicity and allergenicity evaluation of transgenic seeds, plants and plant parts.

21 Acts/ Guidelines Objectives Scope Seeds Bill (2010) Bill provides for regulating quality including health of seeds for import/ export to facilitate their national production and supply All import of seeds subject to Plant Quarantine Order, 2003 conform to minimum limits of germination, genetic and physical purity, and seed health and information on transgenic events/ traits Thank you all