Biodiversity-based Biotechnology in Brazil: Regulatory and Institutional Challenges

The report identifies that while Brazil has immense biological potential, biodiversity-based biotechnology is constrained by a complex and fragmented regulatory environment. The Access and Benefit-Sharing (ABS) framework, particularly the SISGEN system and benefit-sharing rules, is described as a barrier to innovation that creates legal uncertainty and discourages investment. In the Amazon, these hurdles are compounded by infrastructure gaps and weak institutional coordination. The authors argue that the forthcoming National Bioeconomy Development Plan (PNDBIO) is a critical opportunity to explicitly integrate biodiversity-based biotechnology into Brazil's national strategy to unlock economic value and support conservation.

• The Access and Benefit-Sharing (ABS) framework is identified as the primary regulatory hurdle for biodiversity-based biotechnology, creating more complexity and legal uncertainty than other sectoral regimes.
• The National System for the Management of Genetic Resources and Associated Traditional Knowledge (SISGEN) is described as cumbersome and non-intuitive, particularly for smaller actors and foreign users, which hinders compliance.
• Benefit-sharing mechanisms have failed to meet expectations for generating resources for biodiversity conservation and Indigenous Peoples and Local Communities (IPLCs) due to extensive legal exemptions and operational delays.
• CGEN Resolution no. 47 (August 2025) introduces reference lists of traditional knowledge that may increase bureaucracy and risk excluding communities lacking the capacity to engage in administrative processes.
• Brazil's ABS requirements for foreign companies, such as the need for a local representative and the use of Material Transfer Agreements (MTAs), discourage international investment and scientific collaboration.
• In the Amazon, biodiversity use is more strongly linked to traditional knowledge of identifiable origin and non-monetary benefit-sharing compared to the national average, yet the region suffers from severe infrastructure and coordination gaps.
• The National Bioeconomy Development Plan (PNDBIO) currently lacks explicit references to biodiversity-based biotechnology in its strategic missions, risking a narrow focus on biomass and bioenergy.

APA

Climate Policy Initiative (2025). Biodiversity-based Biotechnology in Brazil: Regulatory and Institutional Challenges. https://www.climatepolicyinitiative.org/publication/biodiversity-based-biotechnology-in-brazil-regulatory-and-institutional-challenges/

Chicago

Climate Policy Initiative. Biodiversity-based Biotechnology in Brazil: Regulatory and Institutional Challenges. 2025. https://www.climatepolicyinitiative.org/publication/biodiversity-based-biotechnology-in-brazil-regulatory-and-institutional-challenges/.

Wikipedia

{{cite report |author=Climate Policy Initiative |title=Biodiversity-based Biotechnology in Brazil: Regulatory and Institutional Challenges |date=2 October 2025 |url=https://www.climatepolicyinitiative.org/publication/biodiversity-based-biotechnology-in-brazil-regulatory-and-institutional-challenges/ |access-date=17 August 2026 |via=Climate Insights Directory}}

BibTeX

@techreport{climatepolicyinitiative2025biodiversitybased, author = {{Climate Policy Initiative}}, title = {{Biodiversity-based Biotechnology in Brazil: Regulatory and Institutional Challenges}}, institution = {Climate Policy Initiative}, year = {2025}, month = oct, url = {https://www.climatepolicyinitiative.org/publication/biodiversity-based-biotechnology-in-brazil-regulatory-and-institutional-challenges/}, urldate = {2026-08-17}, note = {Indexed by Climate Insights Directory} }