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PRIOR INFORMED CONSENT IN ACCESS TO TRADITIONAL
KNOWLEDGE IN BRAZIL Sandra Akemi Shimada
Kishi skishi_at_prr3.mpf.gov.br -
CHARACTERISATION OF PIC - WHEN PIC IS
REQUIRED - PROCEDURE AND REPRESENTATION FOR PIC
- TK CLAIMED BY SEVERAL COMMUNITIES (CASE
STUDY KRAHÔ) - OWNERSHIP REGIME OVER TRADITIONAL
KNOWLEDGE - LEGAL QUALIFICATION OF PIC -
MATERIAL CONTENT
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CHARACTERISATION OF PIC - IN THE BRAZILIAN LEGAL
SYSTEM PIC IS AIMED AT VALIDATING THE
AUTHORIZATION OF ACCESS TO ASSOCIATED TRADITIONAL
KNOWLEDGE. - PIC - SELF-DETERMINATION OF
TRADITIONAL PEOPLES SHALL BE ASSURED. THIS
IMPLIES THAT THE HOLDERS OF KNOWLEDGE AND THE
REPRESENTATIVES OF A TRADITIONAL COMMUNITY MUST
BE IDENTIFIED. - PIC PROVIDES A LEGAL LINK
BETWEEN INDIGENOUS AND MINORITY LAW AND THE LAW
OF THE SURROUNDING SOCIETY. - PIC PROVIDES A
BASIS FOR ACHIEVING FAIR BENEFIT SHARING. - PIC
IS A PROCEDURE, NOT A SIMPLE ACQUIESCENCE, IN
SPITE OF THE FACT THAT THE TERM ACQUIESCENCE IS
USED IN PROVISIONAL MEASURE, MP 2186-16/2001
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• WHEN PIC IS REQUIRED
• ACCESS TO TK FOR COMMERCIAL PURPOSES
• ACCESS TO TK FOR RESEARCH PURPOSES (IN THE DRAFT
  LAW REMOVED?)
• ACCESS TO TRADITIONAL TERRITORY

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PROCEDURE AND REPRESENTATION FOR PIC - LEGAL
CAPACITY OF INDIANS. - BRAZILS NEW CIVIL CODE
RECOGNIZES THAT THE STATES GUARDIANSHIP OVER
INDIANS DOES NOT PROVIDE FOR LEGITIMATE
REPRESENTATION OF THEIR INTERESTS, AND STIPULATES
THAT THE CAPACITY OF INDIANS SHALL BE REGULATED
BY SPECIAL LEGISLATION.
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- TRADITIONAL COMMUNITIES DO POSSESS LEGAL
PERSONALITIES, ALTHOUGH NOT PRECISELY AS EITHER
PUCLIC-LAW OR PRIVATE-LAW LEGAL PERSONS. -
TRADITIONAL COMMUNITIES TAKE ON THEIR OWN
REPRESENTATION THROUGH PIC, EXERCISING THEIR
FUNDAMENTAL RIGHT TO SELF-DETERMINATION. -
TRADITIONAL COMMUNITIES MUST BE REPRESENTED BY
THEMSELVES OR THROUGH THEIR ORGANIZATIONS, ALWAYS
IN ACCORDANCE WITH THEIR OWN TRADITIONS AND
CULTURAL VALUES (ART. 232 OF THE 1988 FEDERAL
CONSTITUTION) BUT HOW TO IDENTIFY IN THE
TRADITIONAL COMMUNITY WHO WILL BE ABLE TO
REPRESENT THE INTERESTS OF THE COMMUNITY IN THE
PIC?
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- PERSONS OR A GROUP OF PERSONS FROM A SPECIFIC
TRADITIONAL COMMUNITY, GROUPED OR ELECTED
ACCORDING TO THEIR TRADITIONAL FORMS OF
POLITICAL-SOCIAL ORGANIZATION, ACTING IN THEIR
OWN NAME, IN THE GENERAL INTEREST OF THE
COMMUNITY (SUBSTITUTION).
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SEVERAL COMMUNITIIES CLAIMING THE SAME TK HOW
TO IDENTIFY WHICH COMMUNITY MUST BE CONSIDERED AS
A TRADITIONAL KNOWLEDGE HOLDER? THE PRAXIS
EXPERIENCED IN BRAZIL HELPS TO INDICATE
INSTRUMENTS TO IDENTIFY THOSE COMMUNITIES. WE
WILL TALK ABOUT ONE EMPIRICAL CASE IN BRAZIL.
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CASE STUDY TRIBO KRAHÔ Case of access by the
Federal University of São Paulo (UNIFESP) to
plants used in medicinal rituals and traditional
practices of the Krahô peoples in the State of
Tocantins. A) Of the 400 species collected, 138
were scientifically identified as having
potential neurological action and 11 of these
have already been targeted for pharmacological
and phyto-chemical studies. B) 2 associations
said they represented the Krahô peoples the Wity
Katy and the Kapey. Only one of them the Wity
Katy however, was initially consulted and they
agreed. As to the Kapey, they had not
participated from the beginning in the PIC
procedure nor agreed to the use of genetic
material. In spite of this the plants were
collected. C) In 2002 Kapey asked an
indemnification of five million reais for moral
damages, plus a prospecting fee of twenty million
reais. This is approximately 10 million Euros, in
total.
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-The lack of representation of Kapey caused a
breakdown of the negotiations. - This
experience demonstrates that, in addition to the
lack of debates, and intense exchanges of
information about access in the PIC procedure and
the inability of the national legislation to
protect this traditional Krahô knowledge, there
were no instruments to protect knowledge, such as
an inventory and an independent anthropological
study, which would have identified all the
peoples holding traditional knowledge at the
beginning of the PIC procedure, prior to access,
avoiding the exclusion of any village from the
exchange of information and mutual agreements,
and protecting the shamanic practices in the
collection and use of the biological resources.
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- Perhaps this case was the reason for the CGENs
regulates (Resolution 6, on June 26, 2003 as well
as Resolution 12 on March 25, 2004) the formal
independent anthropological studies to be carried
out prior to PIC in order to assure
representation, through the knowledge holders
identified in that study. - The capability of
communicating between the various ethnic groups
settlements in Brazil is very quick and
efficient, despite the vast distances. One major
means is the yearly Kuarup ritual festival
bringing many ethnic groups together. - Tendency
to be even more expedite, after the arrival of
the digital inclusion program in the villages by
the Social Integration Ministry in August 2007.
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- The independent anthropological study will be
useful to structure an appropriate PIC process.
- The anthropological study must be presented
together with the PIC, to prove that the rights
to otherness and to self-determination have been
observed. - This independent study should
consist of a study with cooperative contributions
from various inter-sciences sociology,
ethnology, ethno-botany, biology, para-taxonomy,
genetic engineering, ethno-pharmacology,
biochemistry, law, environmental economics and
others that interface with the subject matter. -
The anthropological study will determine whether
it is the shaman, the chief or the entire
community and explain how the knowledge has been
held in time and space.
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- Independent anthropological study - in case of
doubt, would be useful in the PIC procedure to
clarify the link with the primary source of
traditional knowledge. - The professional
preparation of the multidisciplinary team doing
the anthropological study will also help, later
on, to better verify the existence or absence of
any additional technological innovation that
might allow for intellectual property protection.
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Ownership regime over traditional knowledge -
Even when only one person in the community holds
the traditional knowledge, it may be deemed to be
held by the community. (sole paragraph of Article
9 in MP 2186-16/2001). - Therefore, in some
cases, the entire tribe must be consulted about
the use of an asset considered to belong to all.
- For most indigenous peoples, traditional
medicinal knowledge is restricted to the shaman,
but to be reproduced beyond members of the tribe,
it must be authorized by the people who hold the
knowledge. - In this common property regime,
ethnic groups follow general rules, namely the
right to organize their activities, develop clear
and easily enforceable rules, respect nature and
apply cheap and rapid methods to resolve minor
conflicts, amongst other criteria.
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- The link between that customary law and
statutory law in the matter of ownership over
traditional knowledge is the systematic
interpretation of some constitutional provisions
- the preamble, art. 3, 215, par. 1 216, 231,
232, 127 and 129, III, V - which leads us to
conclude that rights regarding associated
traditional knowledge can be legally classified
as collective rights or diffuse interests. -
The CBD provisions and the principles regarding
the PIC, which was incorporated as a norm in
brazilian legal system, also should be consider a
link between customary law and statutory law. -
The possession of these meta-individual interests
is legally recognized, allowing for their
collective defense.
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• LEGAL QUALIFICATION OF PIC
• PIC LEADS TO THE DUE PROCESS OF FORMALIZING THE
  ACCESS CONTRACT.
• THUS, PIC CONSISTS OF A KIND OF DRAFT CONCESSION
  CONTRACT, ACTUALLY A PRECONTRACT, WHICH IS A
  REGULATORY BASIS TO CONTROL ACCESS AND TO PUT THE
  PROVIDER IN A BETTER POSITION TO NEGOCIATE THE
  FINAL TERMS OF THE CONTRACT.

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- AN ANALOGY COULD BE MADE WITH THE TAC (TERMO DE
AJUSTAMENTO DE CONDUTTA), A PECULIAR LEGAL
INSTITUTE OF THE BRAZILIAN LEGAL SYSTEM (LAW
7347/1985- LAW OF CLASS ACTIONS SUITS) TO ENSURE
EFFECTIVENESS OF OBLIGATIONS INVOLVING DIFFUSE OR
COLLECTIVE INTERESTS. - TAC IS A KIND OF
CONTRACT INCLUDING AN ENFORCEABLE LEGAL TITLE.
- PIC SHALL BE CONSIDERED A KIND OF THAT TAC.

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• MATERIAL CONTENT OF PIC
• ITS NOT FIXED BY LAW.
• THERE ARE RECOMMENDED CONTENT OF PIC. ACTUALLY,
  IN PIC THE ACCESS-SEEKER MUST AT LEAST
• 1) DISCLOSE THE NATURE AND THE TARGET OF THE
  ACTIVITY
• 2) EXPLAIN ALL POTENTIAL RISKS THAT MAY OCCUR
• 3) DISCLOSE THE PROJECT METHODOLOGY
• 4) IDENTIFY THE APPLICANT LEGAL ENTITY OR
  INDIVIDUAL, THE APPLICANTS SPONSORS, PUBLIC OR
  PRIVATE ENTITIES SUPPORTING THE APPLICANT AND
  COLLABORATORS IN THE RESEARCH
• 5) IDENTIFY THE BENEFITS TO BE SHARED AND THE
  MECHANISMS TO SHARE THE BENEFITS
• 6) INDICATE THE ROYALTIES THAT THE PROVIDER WILL
  RECEIVE FOR THE USE OF THE ACCESSED GOOD.

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• 7) INDICATE POSSIBLE ALTERNATIVE ACTIVITIES AND
  PROCEDURES
• 8) ASSURE THAT THE PROVIDER WILL BE INFORMED AND
  PARTICIPATE SHARING IN DISCOVERIES DURING THE
  COURSE OF THE ACCESS ACTIVITIES, IN WHICH CASE AN
  ADDITIONAL PIC WILL BE REQUIRED
• 9) INFORM PRECISELY THE INTENDED USE, ANY
  COMMERCIAL INTEREST AND THE CURRENT AND POTENTIAL
  USES
• 10) INDICATE DE GUIDELINES THE RESEARCHER IS
  FOLLOWING AND PRACTICES USED IN SIMILAR PROJECTS
• 11) INFORM THE RISK ASSESSMENT OF ACCESS AND
  POSSIBLE ENVIRONMENTAL AND SOCIO-ECONOMIC
  IMPACTS.
• 12) INFORM THE SOURCE AND THE SPECIFICATIONS OF
  THE GENETIC RESOURCE OR THE TK TO BE ACCESSED,
  WHILE ASSURING SECRECY REGARDING THE CONTENT OF
  THE TRADITIONAL KNOWLEDGE.

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CONCLUSION Implementation of the PIC procedure,
with exchange or information, data and
instruments for the protection of traditional
knowledge, including the anthropological study,
makes the PIC-procedure a tool that - catalyzes
the different interests involved, - constitutes
the regulatory link of indigenous or minority law
with statutory law, - assures the identification,
the appropriate representation of traditional
communities, - controls access, facilitates the
exchange of information, - helps the due process
of formalizing the access contract, and -
provides more possibilities to enforce binding
conditions. THANK YOU!