Bio-piracy: International

and National Legal

Framework

International Legal
Framework
Convention on Biological Diversity (CBD) 1992
Principle 22
Indigenous people and their communities and other local
communities have a vital role in environmental management
and development because of their knowledge and traditional
practices. States should recognise and duly support their
identity, culture and interests and enable their effective
participation in the achievement of sustainable development.
Under the CBD, prior informed consent is the standard for
ensuring a fair and equitable ABA. The source country providing
access to genetic resources must know in advance what will be
done with the resource, and what benefits will shared.

Nagoya Protocol on Access to Genetic

Resources and the Fair and Equitable Sharing
of Benefits Arising from Their Utilization
It provides a transparent legal framework for the effective
implementation of one of the three objectives of the CBD:
the fair and equitable sharing of benefits arising out of the
utilization of genetic resources. The Nagoya Protocol on
ABS was adopted on 29 October 2010 in Nagoya, Japan.
The Nagoya Protocol will create greater legal certainty and
transparency for both providers and users of genetic
resources by:
- Establishing more predictable conditions for access to
genetic resources.
- Helping to ensure benefit-sharing when genetic resources
leave the country providing the genetic resources

Nagoya Protocol on Access to Genetic

Resources and the Fair and Equitable Sharing
of Benefits Arising from Their Utilization
Article 15
All Parties to the Nagoya Protocol are obliged to take
measures to provide that genetic resources utilized within
their jurisdiction have been accessed in accordance with
prior informed consent (PIC), and that mutually agreed
terms (MAT) have been established, if such PIC and MAT are
required by the domestic access and benefitsharing (ABS)
legislation or regulatory requirements of the other Party.
Article 16 of the Nagoya Protocol mirrors the obligations
of Parties under Article 15 but with a specific focus on
traditional knowledge associated with genetic resources.

Conflict between CBD and

TRIPS (?)
TRIPS Agreement (Article 27) under the
WTO, recognized IPRs. But these IPRs were
to be private rights and it provided for
rewarding inventions without referring to the
source of biological material and associated
Traditional Knowledge.
There was no commitment for fair and
equitable sharing of benefits with the
country of origin of such knowledge.

Conflict between CBD and

TRIPS (?)
The CBD came into force in 1993 and TRIPS in 1995 and
neither treaty states that it is subject to the other.
Article 22 of the CBD states that the CBD shall not affect
the rights and obligations of any Contracting Party deriving
from any existing international agreement. TRIPS was not
in existence at the time the CBD came into force.
Article 30 of the Vienna Convention on the Law of Treaties
deals with the interpretation of successive treaties relating
to the same subject matter.
But are the CBD and TRIPS dealing with the same matter?

India and CBD

National Legal Framework

National Policy and Macrolevel Action
Strategy on Biodiversity (1999)
Main goals put forth in the NPMASB:
securing the participation of State Governments, local communities
and people, NGOs, industry and other interested parties;
realizing the value of biodiversity through research and development;
and ensuring that India gets the benefits as being the country of
origin of biological resources,
and that its indigenous communities and people get the benefits as
being the conservers of biodiversity, creators and holders of
traditional knowledge systems, innovations, and practices.
Keeping in line with these goals, India took the following legislative and
proactive steps.

Plant Varieties Protection and

Farmers Rights Act (PVPFR) 2001,
and Rules 2013
These two pieces of legislation ensure the
protection of plant breeders rights over
new varieties they develop and give
farmers the entitlement to register new
varieties and also to save, breed, use,
exchange, share or sell the plant varieties
that farmers have developed, improved
and maintained over many generations.

Patent Second Amendment Act 2002 and Patent

Third Amendment Act 2005, amending its Patents
Act 1970
These amendments prohibit the granting of patents for
plants, animals, and traditional knowledge.
Furthermore, Indias patent laws now require
mandatory disclosure of source and geographical origin
of the biological material in the specification when used
in an invention.
Should a party fail to disclose this information, or
participate in wrongful-disclosure, then the amendments
permit opposition to, or revocation of, the patent.

Biological Diversity Act of 2002

Per the Article 15 provision of the CBD, the Act regulates access to biological
resources and associated traditional knowledge to ensure equitable sharing
of benefits arising out of their use.
The Act mandated the implementation of its provisions through the National
Biodiversity Authority (NBA), an autonomous body advising the Central
Government of India on conservation matters, sustainable use of biological
resources, and fair and equitable sharing of benefits arising out of the use of
such resources.
Analogously, State Biodiversity Boards (SBBs) advise State Governments on
the same issues, but subject to guidelines issued by the Central
Government. At the local level, there are Biodiversity Management
Committees (BMCs) that promote conservation, sustainable use, and
documentation of biodiversity.
In December 2012, the First National Biodiversity Congress 2012 (Congress)
was held in Kerala, India. It was organized by the Ministry of Environment
and Forest, the NBA, and SBBs to address several biodiversity issues,
including the management of traditional knowledge and access and benefit
sharing of genetic resources.

TKDL and Bio-piracy

Indias Traditional Knowledge Database Library, a
database containing 34 million pages of formatted
information on some 2,260,000 medicinal
formulations in multiple languages, is a collaborative
project between the Council of Scientific and
Industrial Research (CSIR), and the Department of
AYUSH, is a home-grown effort to ensure patent
offices around the world do not grant patents for
applications founded on Indias wealth of age-old TK.
The idea to establish a TKDL came to the fore amid
Indias efforts to revoke the patent granted by the
United States Patent and Trademark Office (USPTO)
on the wound healing properties of turmeric, and the
patent granted by the European Patent Office (EPO)

TKDL and Bio-piracy

Around the time the TKDL was established in 2001, the
TKDL expert group estimated that, annually, some 2,000
patents relating to Indian medicinal systems were being
erroneously granted by patent offices around the world.
Since July 2009, 215 patent applications relating to Indian
medicinal systems for which third party TKDL evidence
has been filed have been identified. In two such cases the
EPO has already reversed on the strength of TKDL
evidence its earlier intention to grant the patents.
It is evident that India is on the right path when it comes
to protecting its national interest in its biodiversity and
traditional knowledge, while granting access on a caseby-case basis. The issue of benefit sharing is tantamount,
and India must now adopt a balanced approach to
safeguard its genetic resources while promoting much

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