1. Biological Diversity Act: Significance in Bioentrepreneurship
Prakash Nelliyat
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 ( species loss per day !) An irreversible damage and consequences are innumerable.
Formation of CBD (1993); 196 members as partners.

3. Fair and equitable sharing of benefits
CBD Objectives
Conservation
Sustainable use
Fair and equitable sharing of benefits

4. Access and Benefit Sharing (ABS)
The 10th CoP 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 knowledge by 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.
Philosophy proposes 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
Forests
Water body
Paddy fields
Garden
Medicinal plants
Honey
Timber
Fish
Fruits
Grains
Seeds

8. Bio-resources Valuation: Property Right Issues
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
IN – SITU Cons…
Eco-system and Natural Habitation
EX – SITU Cons…
Botanical Garden, Zoo, Gene Banks, Commercial / University Collection, …….

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.

13. Genetic or Bio-resources
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)

14. With and without the Purview of ABS

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

16. 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 (The objectives of the Act are similar to those of the CBD - ABS key)
Issued various notifications under the Act
Come up with the ‘Guidelines on 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.

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

18. 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.

19. 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)

20. Categories of ABS Applications ABS 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

22. 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 :
Annual Gross ex-factory sale of product
Benefit sharing component
Up to Rupees 1,00,00,000
0.1 %
Rupees 1,00,00,001 up to 3,00,00,000
0.2 %
Above Rupees 3,00,00,000
0.5 %
If applicant himself commercialize the process/product/innovation
0.2 – 1.0% of Annual Ex-factory gross sale (minus govt. taxes)
If applicant assigns / licenses the process / product / innovation to a third party for commercialization
3.0 – 5.0 % of the fee received in any form.
And 2.0 – 5.0 % of Royalty
3.0 – 5.0% of high is due to monopoly - IPR
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.

24. 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.
To collaborative 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.

25. Offence under the Act is cognizable and non-bailable – (Section 58)
Offences under the Act
Offence under the Act is cognizable and non-bailable – (Section 58) 25

26. 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) ?!

27. 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

28. Thank You