Experiences with implementation of Brazilian A & BS Regime and Suggestions for Reform
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Transcript of Experiences with implementation of Brazilian A & BS Regime and Suggestions for Reform
![Page 1: Experiences with implementation of Brazilian A & BS Regime and Suggestions for Reform](https://reader030.fdocuments.net/reader030/viewer/2022032313/56812be4550346895d9059cb/html5/thumbnails/1.jpg)
Experiences with implementation of Brazilian A & BS Regime and
Suggestions for Reform
Juliana Santilli
![Page 2: Experiences with implementation of Brazilian A & BS Regime and Suggestions for Reform](https://reader030.fdocuments.net/reader030/viewer/2022032313/56812be4550346895d9059cb/html5/thumbnails/2.jpg)
Historical background
● Brazil was one of the first megadiverse countries to enact national legislation on A & BS.
● Medida Provisória (Decree) nº 2.186-16/2001 regulates access to genetic resources, protection and access to traditional knowledge, benefit sharing and technology transfer.
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● 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
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Current A & BS legal regime
● Bilateral system: contracts between providers and users.
● Main legal instruments:
1) Access Authorization;
2) Benefit-sharing contracts.
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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
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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.
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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
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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
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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
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- 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
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- 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
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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
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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.
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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
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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;
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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.
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- 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
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- 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
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- 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
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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
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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
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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
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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