Experiences with implementation of Brazilian A

1

• Experiences with implementation of Brazilian A
  BS Regime and Suggestions for Reform

Juliana Santilli
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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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Historical background

• 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).

4
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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Current A BS legal regime

• 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 Councils meetings, but have
  no right to vote

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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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Current A BS legal regime

• 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.

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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.

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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).

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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 providers approval)
• - in any case, the benefit-sharing contract
  must be signed before the development of any new
  commercial product, and before any patent
  application.

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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.

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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.

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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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Major shortcomings

• 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).

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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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Major shortcomings

• - 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.

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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.

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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).

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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.

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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.

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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.

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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.