PRIOR INFORMED CONSENT IN ACCESS TO TRADITIONAL KNOWLEDGE IN BRAZIL

Sandra Akemi Shimada Kishiskishi@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

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

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

CONTRACT +CONSENT FROM CGENTO THE CONTRACT

AUTHORIZATION +TTM (MATERIALTRANSFERAGREEMENT) + TERMOF RESPONSABILITY

WITHOUT PIC ANDAUTHORIZATION.

ACCESS TOBIOLOGICALMATERIAL ONLY FORSPECIAL SCIENTIFICNEEDS (EX: ADNTESTS)

CONTRACT +CONSENT FROM CGENTO THE CONTRACT

AUTHORIZATION +TTM (MATERIALTRANSFERAGREEMENT) + TERMOF RESPONSABILITY

WITH PIC (IF TK ISINVOLVED),

WITHOUTAUTHORIZATION

ACCESS TOBIOLOGICALMATERIAL FORSCIENTIFIC OREDUCATIONAL NEEDS

CONTRACT +CONSENT FROM CGENTO THE CONTRACT

AUTHORIZATION +

+ TTM (MATERIALTRANSFERAGREEMENT) + TERMOF RESPONSABILITY

WITHOUT PIC,

WITHAUTHORIZATION

ACCESS OF GENETICRESOURCES IN APRIVATE AREA TOSCIENTIFIC RESEARCHWITH NO POTENTIALPRIORY IDENTIFIEDUSE

BENEFIT SHARINGEXPORTUSEACCESS TORESEARCH

CURRENT JURIDICAL PROTECTION IN BRASIL FOR RESEARCH (MP2.186-16/2001)

CURRENT JURIDICAL PROTECTION OF ACCESS TO BIOPROSPECTION

CONTRACT + CGEN’SCONSENT TO THECONTRACT +INDEPENDENTANTHROPOLOGICALREPORT

SAMPLE’S GR DEPOSIT+ TTM - MATERIALTRANSFERAGREEMENT + TERMOF RESPONSABILITY +INDEPENDENTANTHROPOLOGICALREPORT

PIC + AUTHORIZATION+ CONTRACT + FUNAI‘S ADMINISTRATIVEPROCEDURE (IF ININDIGENOUS AREA)

ACCESS OF TK IN ATRADITIONALTERRITORY

CONTRACT + CGEN’SCONSENT TO THECONTRACT

SAMPLE’S GR DEPOSITIN A CGEN REGISTERINSTITUTION TTM -MATERIAL TRANSFERAGREEMENT + TERMOF RESPONSABILITY

NO PIC.

OWNER’S AREACONSENT +AUTHORIZATION +CONTRACT

ACCESS OF GR TOBIOPROSPECTION IN APRIVATE AREA

CONTRACT +CONSENT FROM CGENTO THE CONTRACT +INDEPENDENTANTHROPOLOGICALREPORT

SAMPLE’S GR DEPOSITIN A CGEN REGISTERINSTITUTION + TTM -MATERIAL TRANSFERAGREEMENT + TERMOF RESPONSABILITY

PIC + AUTHORIZATION+ CONTRACT + FUNAI‘S ADMINISTRATIVEPROCEDURE (IF ININDIGENOUS AREA)

ACCESS OF GR IN ATRADITIONALTERRITORY

BENEFIT SHARINGEXPORTUSEACCESS OF GROR/AND TK TOBIOPROSPECTION ORWITH PERSPECTIVEOF COMMERCIALUSE

PROCEDURE AND REPRESENTATION FOR PIC

- LEGAL CAPACITY OF INDIANS.

- BRAZILS’ NEW CIVIL CODE RECOGNIZES THAT THE STATE’S 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”.

- 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?

- 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).

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.

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.

-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.

- Perhaps this case was the reason for the CGEN’s 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.

- 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.

- 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.

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.

- 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.

• 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.

- 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.

• MATERIAL CONTENT OF PIC

• IT’S 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 APPLICANT’S 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.

• 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.

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!