Until 2015, Brazil had a legal framework for access to biodiversity and associated traditional knowledge that, although pioneering, did not encourage the use of this natural capital for the development of products, processes, and services by the national industry. Excessive bureaucracy, coupled with legal uncertainty, deterred investments and discouraged research, creating a regulatory environment hostile to innovation. The enactment of Federal Law No. 13,123/2015, known as the New Biodiversity Legal Framework, sought to change this scenario. Its objective was to replace the previous model and promote legal security, deregulation, and, consequently, innovation and economic development, positioning Brazil as a global leader in bioeconomy.
Ten years later, the numbers show significant progress. There were 83,974 research projects registered in the National System for the Management of Genetic Heritage and Associated Traditional Knowledge (SisGen), 5,103 registered shipments, and 20,984 notifications of products developed from access to biodiversity. These data show that the law created conditions for greater regularity of research and expansion of sustainable use of national genetic resources and associated traditional knowledge.
However, the implementation of the legal framework is still below expectations. Some critical points deserve attention:
1. National Benefit-Sharing Fund: created to receive and distribute resources from access to genetic resources and traditional knowledge, it has collected only R$ 11,721,296.53 to date – a value much lower than the estimated potential. It was also expected to receive resources from other sources besides benefit-sharing, which did not happen. One of the reasons is possibly the inefficiency in allocating the amounts already collected, which weakens the mechanism and compromises its credibility;
2. Outdated SisGen: since its launch, the system has presented recurring technical problems, from instability to the absence of essential fields. Promised updates have not been fully implemented, preventing the regularization of activities and impacting research and benefit-sharing;
3. Insufficient information for users: companies, research institutions, traditional communities, and other stakeholders still have difficulty obtaining clear and updated information on how to comply with the law. This has led to divergent interpretations, legal uncertainty, and avoidable involuntary errors;
4. Impossibility of regularization of foreign companies: the lack of adaptation of SisGen prevents foreign companies from complying with Brazilian requirements, failing to transfer benefits to the country and remaining in a situation of legal uncertainty. This bottleneck also creates competitive inequality for the national industry, which bears legal obligations while international competitors cannot regularize;
5. Slowness in the analysis of Benefit-Sharing Agreements (ARBs): only 13 proposals have been approved, while 119 are still awaiting analysis, revealing a bottleneck that compromises legal security and investment flow.
6. Risk of revision of consolidated acts and understandings: recent debates indicate possible interpretative revisions that, if implemented, will create legal uncertainty in a sector that requires regulatory stability to innovate.
These factors contribute to Brazil not taking full advantage of its potential as the world’s most megabiodiverse country. Some indicators illustrate this reality. Of the ten best-selling herbal medicines in Brazil, for example, none use species from Brazilian biodiversity. In the list of herbal medicines offered by SUS (Rename), only four of the twelve species used are native.
There is no need for legislative change, but rather more effective and consistent implementation of the existing regulatory framework. Operational adjustments, greater institutional capacity, and clear communication to users are essential measures for Law No. 13,123/2015 to fully fulfill its role of promoting innovation, ensuring fair benefit-sharing, and ensuring biodiversity conservation.
In 2026, the 17th Conference of the Parties (COP) of the Convention on Biological Diversity will be held in Armenia, the most important global forum dedicated to biodiversity conservation and sustainable use. The event will represent a strategic opportunity for Brazil to present itself as an environment favorable to promoting biodiversity-based businesses. For this, the proper implementation of Law No. 13,123/2015 is a fundamental step.
Opinion by João Emmanuel Cordeiro Lima
Lawyer, PhD and Master’s in Law from PUC-SP, is a professor at PUC-SP (Cogeae)
Estadão, January 14, 2026, 3:00 am
