Biodiversity-based Biotechnology in Brazil: Regulatory and Institutional Challenges

This report by the Climate Policy Initiative and the Amazon 2030 project analyzes the regulatory and institutional barriers hindering biodiversity-based biotechnology in Brazil, with a specific focus on the Amazon region. It identifies the Access and Benefit-Sharing (ABS) framework as a primary obstacle to innovation and investment, and suggests that the forthcoming National Bioeconomy Development Plan (PNDBIO) is a critical opportunity to integrate biotechnology into the national strategy.

• The Access and Benefit-Sharing (ABS) framework, governed by Law no. 13,123/2015, acts as a barrier to innovation rather than an incentive. Complexity within the SISGEN electronic platform, delays in approving benefit-sharing agreements, and legal uncertainties regarding Digital Sequence Information (DSI) create an unpredictable environment for researchers, startups, and sectors like pharmaceuticals and cosmetics.
• Benefit-sharing mechanisms have failed to meet expectations for funding biodiversity conservation and supporting Indigenous Peoples and Local Communities (IPLCs). This is due to several factors: legal exemptions for intermediate products and renewable inputs replacing fossil materials, a concentration of obligations in a few industrial sectors, and the poor operationalization of the National Benefit-Sharing Fund (FNRB), which collected only approximately R$ 9.9 million from 2020 to February 2025.
• CGEN Resolution no. 47 (August 27, 2025) introduces reference lists of associated traditional knowledge, which may increase bureaucratic burdens. While intended to provide legal certainty, it risks excluding communities lacking administrative capacity and may force researchers to obtain prior informed consent for a larger share of applied biodiversity research, potentially lengthening project timelines.
• Brazil's ABS framework discourages international cooperation and investment through excessive requirements for foreign entities. Foreign companies must designate a Brazilian representative and cannot rely on the Nagoia Protocol’s ABS Clearing-House for compliance. Additionally, the requirement for Material Transfer Agreements (MTAs) for shipping samples abroad can delay the publication of new species and scientific collaboration.
• Biodiversity-based biotechnology operates in a fragmented institutional environment with limited coordination between national ministries. While the Ministry of Environment and Climate Change (MMA) focuses on sociobiodiversity, the Ministry of Development, Industry, Trade and Services (MDIC) and the Ministry of Agriculture and Livestock (MAPA) prioritize bioindustry and biomass, respectively.
• The Amazon region faces specific structural and regulatory challenges that hinder its biological potential. These include logistical bottlenecks, energy instability, and digital connectivity failures. Furthermore, the requirement for MTAs restricts the taxonomic classification of unknown species, and the presumption that genetic resources are inherently linked to traditional knowledge increases regulatory uncertainty for Amazonian startups.
• The forthcoming National Bioeconomy Development Plan (PNDBIO) is a strategic opportunity to explicitly include biodiversity-based biotechnology. Currently, the plan's draft focuses heavily on biomass and bioenergy, with biotechnology appearing only in the fourth mission related to agricultural and cattle biomass, creating a mismatch between the recognized potential of biodiversity and strategic priorities.

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} }