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Biological Diversity Act: Significance in Bioentrepreneurship

Biological Diversity Act: Significance in Bioentrepreneurship. Prakash Nelliyat Centre for Biodiversity Policy and Law National Biodiversity Authority, Chennai BCIL Workshop on “ Bioentrepreneurship Development” 27 th February, 2018, New Delhi.

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Biological Diversity Act: Significance in Bioentrepreneurship

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  1. Biological Diversity Act: Significance in Bioentrepreneurship PrakashNelliyat Centre for Biodiversity Policy and Law National Biodiversity Authority, Chennai BCIL Workshop on “Bioentrepreneurship Development” 27th February, 2018, New Delhi

  2. Biodiversity Degradation: A Global Challenge Loss of species and ecosystem (45-250 species loss per day !) An irreversible damage and consequences are innumerable. • Formation of CBD (1993); 196 members as partners.

  3. CBD Objectives

  4. Access and Benefit Sharing (ABS) • The 10thCoP of CBD at Nagoya (Japan), 2010 significantly advances on the ‘fair and equitable sharing of benefits’ arising from the commercial utilization of biological resources and associated traditional knowledgeby providing a strong base on legal certainty and transparency ……... (Nagoya protocol) • Sovereign rights to nation on their bio-resources • Innovative approach and an incentive mechanism in biodiversity Conservation and Sustainable use. • Provides a formal guidance for the way in which biological or genetic resources are accessed, and the way benefits are shared between users and providers. • Philosophyproposes that providers of bio-resources are entitled to receive fair benefits from the users (equity & ethics). • Balances the rights of users and providers in BR exchange • Emphasis on “Prior Informed Consent (PIC)” and “Mutually Agreed Terms (MAT)” • Negotiation based on the actual value of the bio-resources (?).

  5. Biological Resources • Bio-resources / Biological resources means: plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material (The Biological Diversity Act, 2002) • Bio-resources: a subset of biodiversity. Biodiversity is a ‘stock’ and bio-resources are ‘flow’ (renewability)

  6. Broader Classification of Biodiversity • Forest Biodiversity • Wetland Biodiversity • Marine biodiversity • Agricultural Biodiversity

  7. Linkages Between Biodiversity and Bio-resources Bio-resources Biodiversity Forests Water body Paddy fields Garden Medicinal plants Honey Timber Fish Fruits Grains Seeds

  8. Bio-resources Valuation: Property Right Issues Bio-resources Natural Environment -------------------------- Public good / property Man-made Environment ------------------------------- Private land / property • Forest • River systems • Estuary • Ocean • Paddy fields • Garden (vegetables, fruits, flowers etc.) • Aquaculture • Livestock • Market distortion • Products under-valued • Price cant act as an incentive for conservation • Market is relatively strong • Price determination based on the cost of production • Prices act as incentive

  9. Types of Genetic or Bio-resources Genetic or Bio-resources EX – SITU Cons… Botanical Garden, Zoo, Gene Banks, Commercial / University Collection, ……. IN – SITU Cons… Eco-system and Natural Habitation

  10. Bio/genetic Resources: Commercial Importance (Bioentrepreneurship) • As source material for: • Developing new drugs. • Botanical medicines • New seed varieties • Ornamental horticultural products

  11. Bio/genetic Resources: Commercial Importance (Bioentrepreneurship) ………. • Crop protection products • Biotechnologies in fields other than healthcare and agriculture • Personal care and cosmetic products.

  12. Commercial Utilization of Genetic or Bio-resources with Respect to ABS / Bio-entrepreneurship Advancement Genetic or Bio-resources Intangible and non-visible (N…) Microbes / Genetic materials Use in limited quantities multiplication (Tech.. R&D) (biotech ind. / seed development… ) Tangible and Visible Bio-resources. Use as raw-material in production. Use in large quantities (botanical, nutraceutical industries)

  13. With and without the Purview of ABS

  14. Bio-product Value Addition Based on actual market value Based on notional value

  15. BIOLOGICAL DIVERSITY ACT & INDIA’s ABS INITIATIVES • India: Party to the CBD and one of the mega-biodiversity country • India enacted the Biological Diversity Act in 2002, and notified the Rules thereunder in 2004. (The objectives of the Act are similar to those of the CBD - ABS key) • Issued various notificationsunder the Act • Come up with the ‘Guidelineson Access to Biological Resources and Associated Knowledge and Benefit Sharing Regulation (2014)’ {provide more clarity for implementing the ABS in the country} • At the state level, different states notified State Specific Biological Diversity Rules for the smooth implementation of ABS.

  16. Institutional Structure for Implementation of BD Act National Biodiversity Authority National State Biodiversity Board State Biodiversity Management Committee Local

  17. Biological Diversity Act: Salient Features • Provide sovereign rights of India over its biological resources • Stops misappropriation of biological resources and associated knowledge (Bio-piracy) • Regulates access & use of Biological resources and / associated knowledge • Ensure sustainable utilisation and equitable benefit sharing • Provide legal recognition & support to the Biological resources and associated traditional knowledge.

  18. Biological Diversity Act Regulates the access of biological resources and associated knowledge for • Research • Commercial utilisation • Bio-survey & bio-utilization • Transfer of results of research • For obtaining IPR in or outside India; • Transfer of accessed biological resources or knowledge to third party • Send /carry the Indian biological resources to abroad for conducting of Non-commercial research (Indians)

  19. Categories of ABS ApplicationsABS agreements under the Act are: Four categories • Form 1 deals with the direct access to biological resources and/ or associated traditional knowledge for the purpose of (a) research, (b) bio-survey and bio-utilization, and (c) commercial utilization. • Form 2 deals with the transfer of research results relating to biological resources from India to a non-Indian. •  Form 3 deals with procuring prior approval from NBA before making applications for intellectual property rights (within and outside India). • Form 4 deals with the transfer of biological resources and/or associated traditional knowledge to any third parties by individuals/entities who have accessed these resources and knowledge through Form 1. • Form B: Conducting of non-commercial research or research for emergency purposes outside India by Indian researchers/ Government institutions

  20. Benefit sharing component: As per the ABS Guideline 2014 • Commercial Utilization: • 2. Transfer of results of research , the benefit sharing obligation is 3.0 to 5.0% of the monetary consideration. • Intellectual Property Rights : • 4. Transfer of accessed bio-resources and TK, the benefit sharing obligation is 2.0 to 5.0% (sectoral approach) of any amount and / or royalty received from the transferee.

  21. Exemptions under the Act Act provides exemption of certain activities from its purview : • To local people and community for free access to use bioresources within India. • To growers and cultivators, vaids and hakims (practitioners of traditional medicinal systems) to use bio-resources. • To biological resources, normally traded as commodities notified by the Central Government under section 40 of the Act. • Tocollaborative research through government-sponsored institutes subject to conformity with guidelines and approval of the Central / State Governments. • To access value added products. • For research by Indians in India.

  22. Offences under the Act Offence under the Act is cognizable and non-bailable– (Section 58)

  23. Challenges and Way Forward • Lack of Awareness and Correct Understanding on the ABS (industry  raw-material security) • Identifying and relying the right stakeholder in the value chain (not easy). Located in different geographical area(community  trader  industry) • Cooperation from stakeholders (Provider  Users) Need Integrated approach with multi stakeholders participation . Reliable economic information • BMCs Empowerment ? (“Biodiversity Literacy”) • Benefit Sharing and Conservation (resources like marine / fish) ?!

  24. CBD/BD Act & ABS Rationale Ecosystem Services • Sequester atmospheric carbon • Moderate weather and hydrological cycle • Cycle nutrient • Spiritual and religious values • Cultural value • Existence value etc., Commercial Value/Products • Benefit Sharing

  25. Thank You

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