» Access and Benefit Sharing
to genetic resources
means to obtain samples of biological and/or genetic material from areas within
national jurisdiction for purposes of research, on conservation, commercial application
or industrial use.
to equitable sharing of benefits, on agreed terms, arising from the use of biological
and/or genetic material with the providers of the material.
While concerns for the environment were expressed in history
but sincere efforts started in 1987 by the World Commission on Environment and Development
Programmes. The efforts by UNEP culminated in the largest ever meeting of the world
leaders commonly known as Convention on Biological Diversity
in 1992 at Rio de janeiro, Brazil. It was the first time when the need for environmentally
sound economic development was recognized globally. A historic set of agreements
were signed during the convention.
Convention on Biological diversity is the first international
legal instrument that brought out a radical change from the then prevailing common
perception on genetic resources as common heritage of mankind to a legally binding
regime that confers sovereign rights to the states over their own biological resources
including genetic resources and traditional knowledge. Following are the three core
objectives of the Convention-
Showing its concern for the conservation and to fulfill
the commitments to CBD India enacted Biological Diversity Act in the year 2002 and
Biological Diversity Rules in 2004.
- Conservation of Biodiversity.
- Sustainable use of the Components.
- Sharing of the benefits arising from the commercial and
other utilization of genetic resources in a fair and equitable way.
The main intent of this legislation is to protect India’s
rich biodiversity and associated knowledge against their use by individuals and
organizations without sharing the benefits arising out of such use and check bio-piracy.
The act has created a three tier institutional mechanism-
The BD Act 2002 stipulates norms for access to biological
resources and traditional knowledge based on three ways-
- National Biodiversity Authority at the apex based at Chennai
- State Biodiversity Boards in all the states
- Biodiversity management committees at the level of all
Before this legislation, access to biological resources
for research, commercial use and taking IPR was an unregulated domain. Historically,
plant genetic resources were used for commercial purpose outside their region of
origin. Bio-prospectors searched for natural substances to develop new commercial
products. Often the products would be sold and protected by the patents by IPR without
any sharing with the source container.
- Access to biological resources and traditional knowledge
to foreign citizens companies and NRIs based on prior approval of NBA Chennai.
- Access permits to Indian citizens, Companies Associations
and other organizations registered in India on the basis of prior intimation to
the State Biodiversity Board concerned (Section 7).
- Exemption of prior approval or intimation for local people
and communities including growers cultivators of biodiversity, vaids and hakims
who have been practising indigenous medicines (Section 7).
Considering the national sovereignty over the genetic resources,
the Act empowers NBA, SBBs and BMCs to regulate access to the biological resources
within their jurisdiction. .It also says that access to valuable genetic resources
be carried out on mutually agreed terms and subject to the prior informed consent
of the BMC of the place/area of its origin. Industries and the commercial users
of the bio-resources should share the benefits/profits again on mutually agreed
terms and conditions
- Prior informed consent
- Mutually agreed terms
- Benefit sharing agreements through monetary and non monetary
It is a set of administrative procedures for deciding on
whether to grant access to genetic resources on defined terms.
Getting a prior informed consent (PIC)
- PIC has to be sought from the owners of the resources.
- In accordance with article 15, paragraph 5 of CBD access
to genetic resource shall be subject toPIC of the contracting party providing such
- There must be legal clarity and certainty.
- There must be consent of the relevant competent authority
as well as the local community.
- There must be timings and deadlines.
- Specification of uses.
- Mechanism for consultation of relevant stake holders.
An application for access could require the following information to be provided
in order for the competent authority to determine whether or not access to genetic
resources should be granted:-
Permission to access genetic resources does not necessarily imply permission to
use associated knowledge and vice versa.
- Legal entity and affiliation of the applicant and/or collector
and contact person when the applicant is an institution.
- Type and quantity of genetic resources to which access
- Starting date and duration of the activity.
- Geographical prospecting area.
- Evolution of how the access activity may impact on conservation
and sustainable use of biodiversity to determine the relative costs and benefit
of granting access.
- Accurate information regarding intended use (e.g. taxonomy,
collection, research, commercialization).
- Identification of where the research and development will
- Information on how the research and development is to
be carried out.
- Possible third party involvement.
- Purpose of the collection, research and expected results.
- Kinds/types of benefit that could come by obtaining access
to the resource, including benefit from derivatives and products arising from the
commercial and other utilization of the genetic resources.
- Indication of benefit-sharing arrangements.
- Treatment of confidential information.
In accordance with Article 15, Paragraph 7 of the Convention
on Biological Diversity, each contracting party shall “ take legislative ,
administrative or policy measures, as appropriate with the aim of sharing in a fair
and equitable way the results of research and development and the benefit arising
from the commercial and other utilization of genetic resources with the contracting
party providing such resources. Such sharing shall be upon mutually agreed terms”.
Following could be considered for development of mutually agreed terms-
- Legal certainty and clarity regarding terms and conditions.
- Provision on user and provider obligation.
- Contractual arrangements for different resources and for
different uses and development of modal agreements.
- Mutually agreed terms should be negotiated efficiently
and within a reasonable period of time.
- Mutually agreed terms should be set out in a written agreement.
- Regulating the use of resources in order to take into
account ethical concerns of the particular parties and stakeholders, in particular
indigenous and local communities concerned.
- Provision to ensure the continued customary use of genetic
resources and related knowledge.
- Provision for the use of intellectual property rights
include joint research, obligation to implement rights obtained on inventions and
to provide licenses by mutual consent.
- The possibility of joint ownership of intellectual property
rights according to the degree of contribution.
- Type and quantity of genetic resources, and the geographical/ecological
area of activity.
- Any limitations on the possible use of the material.
- Recognition of the sovereign rights of the country of
- Capacity-building in various areas to be identified in
- A clause on whether the terms of the agreement in certain
circumstances (e.g. change of use) can be renegotiated.
- Whether the genetic resources can be transferred to third
parties and conditions to be imposed in such cases, e.g. whether or not to pass
genetic resources to third parties without ensuring that the third parties enter
into similar agreements except for taxonomic and systematic research that is not
related to commercialization.
- Whether the knowledge, innovations and practices of indigenous
and local communities have been respected , preserved and maintained, and whether
the customary use of biological resources in accordance with traditional practices
has been protected and encouraged.
- Treatment of confidential information.
- Provision regarding sharing of benefits arising from the
commercial and other utilization of genetic resources and their derivatives and
- Mutually agreed terms could cover the conditions, obligations,
procedures, type, times, distribution and mechanisms of benefits to be shared. These
will vary depending on what is regarded as fair and equitable in light of the circumstances.
- Types of benefit - Monetary and non-monetary benefits.
- Timing of benefits- Near- term, medium-term and long-term
benefits should be considered, including up-front payments, milestone payments and
royalties. The time- frame of benefit-sharing should be definitely stipulated. Furthermore,
the balance among near-term, medium-term and long term benefit should be considered
on a case-by-case basis.
- Distribution of benefit-Pursuant to mutually agreed terms
established following prior informed consent, benefits should be shared fairly and
equitably with all those who have been identified as having contributed to the resource
management, scientific and /or commercial process. The latter may include governmental,
non-governmental or academic institutions indigenous and local communities. Benefit
should be directed in such a way as to promote conservation and sustainable use
of biological diversity.
- Mechanisms for benefit sharing – Mechanisms for
benefit-sharing may vary depending upon the type of benefits, specific conditions
in the country and the stakeholders involved. The benefit sharing mechanism should
be flexible as it should be determined by the partners involved in benefit sharing
and will vary on a case-by-case basis.
- Mechanisms for sharing benefit should include full cooperation
scientific research and technology development, as well as those that derive from
commercial products including trust funds, joint ventures and licenses with preferential
IPR over the Bio-resource
Section 6 of the BD Act:
- No person shall apply for any IP right, by whatever name
called, in or outside India for any invention based on any research or information
on a biological resource obtained from India without obtaining the previous approval
of the NBA before making such application:
Provided that if a person applies for a patent, permission of the NBA may be obtained
after the acceptance of the patent but before the sealing of the patent by the patent
Provided further that the NBA shall dispose of the application for permission made
to it within a period of ninety days from the date of receipt thereof.
- The NBA may, while granting the approval under this section,
impose benefit sharing fee or royalty or both or impose conditions including the
sharing of financial benefits arising out of the commercial utilization of such
- The provisions of this section shall not apply to any
person making an application for any right under any law relating to protection
of plant varieties enacted by Parliament.
- Where any right is granted under law referred to in sub-section
(3), the concerned authority granting such right shall endorse a copy of such document
granting the right to the National Biodiversity Authority
» Access & Benefit Sharing
» Biodiversity Management Committees