Biotecnologia da Biodiversidade: Desafios Regulatórios e Institucionais

The report analyzes the intersection of biotechnology, biodiversity, and bioeconomy in Brazil, arguing that while the country possesses immense biological potential, a complex and unpredictable regulatory environment—specifically the Access and Benefit-Sharing (ABS) framework—stifles innovation. It highlights that the SisGen system is cumbersome, benefit-sharing mechanisms are underperforming, and institutional fragmentation across ministries hinders a cohesive national strategy. The authors advocate for the explicit inclusion of 'biodiversity biotechnology' in the PNDBio to transform biological assets into sustainable economic value, especially in the Amazon.

• The regulatory framework for biodiversity, specifically the Access and Benefit-Sharing (ABS) regime, is the primary source of complexity and legal insecurity for biotechnology in Brazil, more so than general biotechnology or bioeconomy regulations.
• Benefit-sharing results are significantly lower than expected; however, in the Amazon, a high proportion of biodiversity-derived products involve identifiable traditional knowledge (CTA), meaning direct sharing with local communities is more frequent there than nationally.
• The National Management System for Genetic Heritage and Associated Traditional Knowledge (SisGen) is characterized by a non-intuitive interface and excessive data requirements, creating compliance barriers for startups and small businesses.
• CGen Resolution No. 47/2025, which creates reference lists for traditional knowledge, may increase bureaucracy and legal uncertainty by potentially requiring prior informed consent for a larger portion of academic research.
• The National Benefit-Sharing Fund (FNRB) has been largely ineffective, collecting approximately R$ 9.9 million between 2020 and February 2025, with resources only beginning to be distributed in June 2025 via the 'Guardiões da Sociobiodiversidade' award.
• International cooperation is hindered by the requirement for foreign companies to have a national representative and Brazil's lack of integration with the Nagoya Protocol's ABS Clearing-House (ABSCH).
• The requirement for a Material Transfer Term (TTM) for sending genetic samples abroad delays scientific research and the publication of new species, potentially leading to 'jurisdiction shopping'.
• There is a significant institutional disconnect between ministries; the MMA focuses on sociobiodiversity, while MDIC and Mapa emphasize bioindustry and biomass, respectively, leading to a fragmented environment for biodiversity biotechnology.
• The National Bioeconomy Development Plan (PNDBio) currently fails to explicitly include biodiversity biotechnology in its strategic missions, risking a reduction of the bioeconomy agenda to biomass and bioenergy.
• Financial barriers persist for biotechnology startups in health, pharmaceuticals, and cosmetics, which face more limited access to specialized investors compared to the agrotech sector.

APA

Climate Policy Initiative (n.d.). Biotecnologia da Biodiversidade: Desafios Regulatórios e Institucionais. https://www.climatepolicyinitiative.org/wp-content/uploads/2025/10/Biotecnologia-da-Biodiversidade.pdf

Chicago

Climate Policy Initiative. Biotecnologia da Biodiversidade: Desafios Regulatórios e Institucionais. n.d. https://www.climatepolicyinitiative.org/wp-content/uploads/2025/10/Biotecnologia-da-Biodiversidade.pdf.

Wikipedia

{{cite report |author=Climate Policy Initiative |title=Biotecnologia da Biodiversidade: Desafios Regulatórios e Institucionais |url=https://www.climatepolicyinitiative.org/wp-content/uploads/2025/10/Biotecnologia-da-Biodiversidade.pdf |access-date=23 October 2026 |via=Climate Insights Directory}}

BibTeX

@techreport{climatepolicyinitiativendbiotecnologia, author = {{Climate Policy Initiative}}, title = {{Biotecnologia da Biodiversidade: Desafios Regulatórios e Institucionais}}, institution = {Climate Policy Initiative}, url = {https://www.climatepolicyinitiative.org/wp-content/uploads/2025/10/Biotecnologia-da-Biodiversidade.pdf}, urldate = {2026-10-23}, note = {Indexed by Climate Insights Directory} }