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phytotherapy

The price of lack of definition

Researchers from the Cebrid interrupt research with Krah

ELIANA RODRIGUESHutticahãc seems to act on the nervous system ELIANA RODRIGUES

Researchers led by Elisaldo Carlini, the director of the Brazilian Center for Information on Psychotropic Drugs (Cebrid), of the Federal University of São Paulo (Unifesp), decided to halt the project investigating the Krahô phyto pharmacopoeia that they had been carrying out, with the support of FAPESP, in three villages from the tribe’s indigenous reserve in a cerrado (wooded savanna) region of the north of the state of Tocantins. This research, led by biologist Eliana Rodrigues, who is studying for her doctorate under Carlini’s supervision, had already identified 164 species of plants used by the medicine men for medicinal purposes, 138 of which seemed to have the potential for acting on the central nervous system and might be used in the development of new drugs. The project was on the cover of Pesquisa FAPESP nº 70, the November/December 2001 issue.

In spite of the agreement signed with Vyty-Cati, an association that represents two of the 17 villages in Kraholândia (Kraholand) in February 2001, which guaranteed not only access to the material but also the participation of the Indians in the distribution of royalties arising from any patent registration, the research was disallowed. Members of another association of the Krahô, Kapey, dispute the representativeness of Vyty-Cati and call for all the villages to be included in sharing out any benefits that arise from the research. In a document signed by 29 chiefs, medicine men and members of the association, Kapey is demanding from Unifesp compensation in an estimated amount of R$ 5 million, under the heading of damages, and a Bioprospecting Fee in the amount of R$ 20 million, “for the work of collecting the plants and of the knowledge coupled with them, passed on by the Krahô medicine men”, before restarting discussions on carrying on with the research. “It was a bucket of cold water”, Carlini laments.

Federal Justice, according to its press department, has been, for several months, looking into at Unifesp’s request, the agreement signed between the indigenous association Vyty-Cati and the university is in order. “My understanding is that the gathering of natural resources from the indigenous area referred to did not observe essential requirements, such as the informed prior consent of all the Indians of the Krahô tribe and an equitable distribution of the benefits”, comments Maria Luiza Grabner, the procurator of the Republic.

Participation in the patent
The intention of Carlini and his group of researchers is to restart the project with other plants, in the region of the pantanal (swampy lands in western Brazil or the caatinga semi-arid), far from areas with indigenous reserves. “Brazil has 55,000 plants”, he recalls. But the interruption of research in Kraholândia has aborted an experience that is without precedent in Brazil: sharing the benefits of knowledge with the traditional communities where they originated. “The Indians are authors of a scientific work. By trial and error, they have discovered the effects of a plant on a given disease. The role of the scientist, our role, in this case, is to test this information”, he says. In spite of the interest in research, the intention was always to protect the interests of the group”, Carlini says .

The project started 1998, after being approved by FAPESP, by the National Council for Scientific and Technological Development (CNPq), by the National Council for Ethics and Research, and having being forwarded to the National Foundation for the Indian (Funai). Funai’s approved it only in July 2001. “In the meantime, we got authorization from the Indians to guarantee our entry into the village”, he recalls. During this period, the researchers and the representatives of the Krahô drew up several drafts of an agreement that was finally signed by Vyty-Cati in February 2001, which guarantees the participation of all the Indians in any patent by Unifesp. In those days, there was already a preliminary understanding between Unifesp, the Krahô and three Brazilian laboratories to exploit medicinal plants. But no agreement was signed.

Throughout the whole of the research, the scientific name of the plants and their possible therapeutic uses were kept secret – they were identified by their names in the timbira language – and all the samples were kept at the Institute of Botany of the State of São Paulo. “Moreover, the method used for collecting them did not allow any phytochemical or pharmacological analysis. Besides having gathered only three sprigs of each species, I used alcohol on the plants, which prevents chemical screening from being carried out on them”, Eliana says.

In November 2001, shortly before defending the thesis that gave rise to the research, the researchers met once again with the representatives from the Krahô, in São Paulo, at a meeting that also had the presence of a lawyer specialized in intellectual property and of an anthropologist, an adviser to the Vyty-Cati, in an attempt to define a proposal for an agreement and to debate the sharing of royalties. A new meeting, in February 2002, brought to the debate the Federal Justice , representatives of the pharmaceutical industry and from Funai. A series of points were obscure. There were, for example, controversies on the legal representativeness of the Indians to sign agreements. ‘The meeting was a bucket of cold water”, Carlini remembers. It was suggested that the research should be suspended until the question of sharing out the benefits had been resolved.

“In May, Kapey invited us to a meeting in Tocantins, for further clarification about the project, otherwise they would take us to court”, Carlini recalls. “But the Indians from Vyty-Cati told us that they would rather discuss the matter amongst themselves. We did not go to the meeting, but we did send a letter placing ourselves at their disposal for an understanding”. It was precisely at this meeting that Kapey decided to demand from Unifesp compensation and a fee for bioprospecting.

Legal Trouble
The absence of legal trademarks to protect biodiversity in Brazil exposes indigenous groups to acts of biopiracy and, at the same time, discourage initiatives, like those of Unifesp, that seek responsible ways of incorporating traditional knowledge into science and sharing results. In Brazil, biodiversity and traditional cultures are protected by Provisional Measure 2186 ( a presidential decree not yet voted by the Congress), of 2001, published after the research had started and after the agreement between Unifesp and Vyty-Cati. The PM conditions access to natural resources to the authorization of the Federal Government, recognizes the right of the indigenous and local communities to decide about the use of their knowledge associated with genetic resources, and provides for the sharing of benefits, if they are used and marketed.

“The benefits resulting from the economic exploitation of the product or process developed from a sample from components of genetic heritage and traditional knowledge obtained by a Brazilian institution or an institution headquarted abroad will be shared, in a just and equitable manner, amongst the contracting parties, in accordance with the provisions of the pertinent regulations and legislation”, runs the text of the PM. Being a provisional measure not yet converted into permanent law, the pertinent regulations and legislation to which the text refers have still not been defined.

The measure created the Council for Management of Genetic Heritage, of a deliberative and normative nature, made up of representatives of organs and entities of the federal public administration. It would be this Council’s responsibility to establish criteria for the authorizations of access and remittance, and guidelines for drawing up the Contract for the Use of Genetic Heritage and Sharing its Benefits. In this case, the absence of regulations justifies the recommendation of the lawyers, presented at the meeting between the researchers from Unifesp and the Indians in February 2002, to suspend the research.

“Unfortunately, the absence of strategies for carrying out the PM dispels the interest of Brazilian researchers in involving themselves with research in the area of traditional knowledge. The knowledge of the Brazilian ethnic groups remains at the mercy of foreigners, who continue to lay hold of the material offered by biodiversity”, laments Cristina Assimakopoulos, the lawyer of Unifesp’s Commission for Intellectual Property.

It is on the basis of this Provisional Measure that the Kapey association wants Unifesp to pay R$ 20 million, in the form of a Fee for Prospecting, to carry on researching. In the chapter on administrative sanctions, there is a provision for the application of a fine “arbitrated by the competent authority, in accordance with the seriousness of the infraction and in the manner of the regulation”, which may vary from R$ 10,000 to R$ 50 million, if the infraction is committed by a corporate body. In the case of any repetition, the fine will be applied in double.

The Aguaruna case
Eight years ago, the Aguaruna Indians, from Peru, experienced a similar situation. The International Cooperative Biodiversity Group (ICBG) put into effect a program for grants – sponsored by the National Institutes of Health, the National Science Foundation and by the United States Agency for International Development – with the intention of “encouraging the conservation of biodiversity and the promotion of activities economically sustained by means of the discovery of drugs originating from natural products”. One of the five grants went to Walter Lewis, from the University of Washington, for work based on the collection of medicinal plants used by the Aguaruna peoples, in the Peruvian Amazonia.

Two Peruvian universities and the pharmaceutical arm of Monsanto, Searle&Co. took part in the agreement. Negotiations started in 1994, and a letter of intent was signed withthe representatives of the Aguarunas. Until 1996, the Aguaruna people did not formally take part in the process, until, in May of that year, they went to the headquarters of Searle, in Saint Louis, with a proposal for renegotiating the agreement, which provided for a know-how license between the company and the group, and compensation for collecting resources and the use of knowledge.

As the Aguaruna organizations represented less than half of the people, the agreement was originally conceived as a non-exclusive license: other groups or peoples would not be prevented from using their right over the use, sharing or sale of their medicinal plants or knowledge, in any part of the world. It was, however, laid down that sharing the benefits would have to take into account the interests of all the groups – even though the collection of the medicinal plants may have taken place only in the communities affiliated to the organization that signed the agreement – and only after a decision taken by a meeting of the community, expressing its desire to take part. Research is under way, and the agreement is regarded by the World Intellectual Property Organization (WIPO) as a successful model for understanding.

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