Experiences with implementation of Brazilian A & BS Regime and Suggestions for Reform Juliana Santilli

Historical background ● Brazil was one of the first megadiverse countries to enact national legislation on A & BS. ● Medida Provisória (Decree) nº /2001 regulates access to genetic resources, protection and access to traditional knowledge, benefit sharing and technology transfer.

● Several proposals have been made to change this legislation. ● The Executive Power has drafted a new legal bill, that is currently open for public consultation (Deadline: February 28th, 2007). Historical background

Current A & BS legal regime ● Bilateral system: contracts between providers and users. ● Main legal instruments: 1) Access Authorization; 2) Benefit-sharing contracts.

1) Access Authorization: - to genetic resouces, subject to prior informed consent of the provider; - to TK, subject to prior informed consent of the provider; - the Access Authorization is granted by the Genetic Resources Council, which is an interministerial body; - representatives of scientists, private sector, Indigenous peoples and NGOs also participate of the Council’s meetings, but have no right to vote; Current A & BS legal regime

1) Access Authorization: - can only be granted by the Genetic Resources Council after the prior informed consent of:. indigenous peoples;. owners of private properties;. public agencies.

2) Benefit-sharing contracts: - mandatory only for commercial bioprospection; - They must be approved by the Genetic Resources Council; - Federal government is always entitled to a certain share of benefits. Current A & BS legal regime

3) Disclosure requirements/IPRs: - any application for patents or other IPRs must inform the origin of the genetic material and TK; - the applicant must sign a declaration that he has fulfilled all A & BS legislation requirements; - he must also present the number and date of the Access Authorization to the patent office. Current A & BS legal regime

4) Commercially-oriented research: - a benefit-sharing contract was mandatory before any authorization to access genetic resources/TK could be granted. - benefit-sharing mechanisms had to be established before the research had even started (and its results were still unknown and unpredictable). Current A & BS legal regime

- a Presidential Decree was issued on July 17th, 2007, establishing that the presentation of the Benefit- Sharing Contract can be postponed by the Genetic Resources Council. (depending on the provider’s approval) - in any case, the benefit-sharing contract must be signed before the development of any new commercial product, and before any patent application. Current A & BS legal regime

- there are no differences between A & BS requirements for scientific research and commercially- oriented research. - certain types of scientific research were exempt (by the Council) from A & BS legislation requirements, especially when access to genetic resources is used only as a methodological tool. Current A & BS legal regime

Examples: - research projects to evaluate the evolutionary history of a species or taxonomic group; - the relationships between living organisms and between them and the environment; - or the genetic diversity of populations, etc. Current A & BS legal regime

Major shortcomings 1) Lack of definition of the legal status of genetic resources: are they public or private goods? Proposals to overcome: - there is a controversial legal bill declaring that all genetic resources are public goods and belong to the Federal State. - other proposals (and the new legal bill) suggest that genetic resources be considered “public-interest” goods.

2) Too much emphasis on property rights. Very few resources go to the conservation of biodiversity. Proposals to overcome: - the new legal bill proposes that benefits be deposited in two public funds:. genetic Resources and TK Benefit-Sharing Fund;. scientific and Technological Fund (50% each). Major shortcomings

3) No differences between scientific and commercially oriented research. Proposals to overcome: - access to genetic resources for scientific purposes does not require an Access Authorization; - exceptions: when foreign or Brazilian institutions with commercial purposes are involved in the scientific research;

Major shortcomings - all information concerning the scientific research must be deposited in a National Research Inventory. - foreign institutions need to be associated with a Brazilian research institution, in order to ask for an Access Authorization.

- if access to genetic resources takes place in territories occupied by Indigenous or traditional peoples, their prior informed consent is required. - access to traditional knowledge (for any purpose) requires an Access Authorization, subject to the prior informed consent of the Indigenous/traditional community. Major shortcomings

- if a scientific research becomes commercially- oriented, it must follow the rules concerning this type of research. - commercially-oriented research projects can only be developed after an Access Authorization has been granted. Major shortcomings

- a new tax is established, as a benefit-sharing mechanism, which must be paid when a new commercial product (derived from access to genetic resources/TK) is commercialized (1%), or when patents or breeders’ rights are granted over such product and royalties are received (2%). - the resources go to specific funds, and must be used to conserve biological and cultural diversity (based on the region of origin of the resource). Major shortcomings

4) TK shared by numerous traditional/Indigenous peoples. Proposals to overcome: - The new legal bill proposes that Indigenous and other traditional communities who provide access to TK are entitled to receive benefits, negotiated through Access and Benefit-Sharing Contracts. - Other communities who share the same traditional knowledge would be entitled to receive benefit through one of the public funds. Major shortcomings

Proposals to overcome: - Indigenous organizations have suggested the creation of collective funds, divided by ecological/ethnographic regions, as a mechanism to share benefits among traditional populations who share knowledge and resources. Major shortcomings

5) Access to “diffuse” traditional knowledge. Proposals to overcome: - no legal obligation to share benefits; - exceptions: commercially-oriented research, developed outside Brazil, and by a foreign institution; - a benefit-sharing contract must be signed between Brazilian authorities and the foreign institution, and the benefits will be deposited in a public fund. Major shortcomings

6) There are no specific provisions regarding access to plant genetic resources (for food and agriculture). Participatory plant breeding is not regulated. Most controversial issues: - landraces (incorporated TK), farmers’ rights, benefit-sharing mechanisms, etc. Major shortcomings