Biodiversity-Based Biotechnology in Brazil: Regulatory and Institutional Challenges

Brazil holds the greatest biodiversity on the planet, and in the Amazon this natural wealth is even more strategic. However, turning this potential into high value-added innovation remains a challenge. A new study by CPI/PUC-Rio and Amazônia 2030, authored by Cristina Leme Lopes (Senior Research Manager, CPI/PUC-Rio), Ana Flávia Corleto (Researcher, CPI/PUC-Rio), and Joana Chiavari (Research Director, CPI/PUC-Rio), shows that biodiversity biotechnology can strengthen production chains, generate economic value, and promote conservation, but faces regulatory and institutional barriers that limit its development.

The authors emphasize that the Legal Framework for Access and Benefit-Sharing of Biodiversity (Biodiversity Law) is at the core of the challenges. Compared to other biotechnology frameworks, Brazil’s system is more complex in terms of governance, implementation, and legal certainty.

The study highlights four key findings:

  • Benefit-sharing falls short of expectations: although designed to support traditional communities and conservation, the mechanism has yet to consolidate itself as a significant source of resources.
  • Regulatory challenges hinder innovation: the complexity of SisGen, delays in approving benefit-sharing agreements, and uncertainties regarding digital sequence information (DSI) create an unpredictable environment. Recent and potential regulatory changes reinforce perceptions of legal insecurity.
  • Additional requirements undermine investment and international cooperation: Brazil’s absence from the ABS Clearing-House of the Nagoya Protocol and the need for extra authorizations to send samples abroad hinder scientific collaboration and discourage foreign companies.

 

The study also shows that biodiversity biotechnology has applications across sectors overseen by different ministries. Yet, public policies still follow fragmented logics, with limited institutional coordination.

Despite recent advances in the broader bioeconomy agenda — encompassing areas such as sociobiodiversity and biomass — biodiversity biotechnology remains undervalued and underrecognized as a strategic priority. This gap is particularly significant in the Amazon, where biotechnology could contribute to diversifying the economy and reducing pressures on the forest.

In this context, the formulation of the National Bioeconomy Development Plan (PNDBio) represents a unique opportunity to explicitly recognize biodiversity biotechnology as a central element of Brazil’s bioeconomy strategy and to strengthen its integration into national policies.

Read the full paper here.

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