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Point Scored: the self-registration system as a positive highlight among the intricacies of the Brazilian legislation on access to biodiversity – Viviane Kunisawa

May 2, 2019

When talking about biodiversity, different ecosystems may come to mind, but the Amazon rain forest is certainly listed. Its representativeness of the Brazilian biodiversity is so striking that, during President Jair Bolsonaro’s trip to the USA in March, both governments signed a letter intending to create an investment fund of over 100 million(USD) to be financed by the private sector, seeking to support the development of sustainable, market-oriented productive models in the Amazon. A few weeks later, in his trip to Israel, President Bolsonaro specifically addressed Brazil’s rich biodiversity and the need to fully exploit it by establishing partnerships, which emphasizes a governmental concern to fuel its economic potential.

Activities pertaining to the use of biological resources may find a great potential in the country indeed. Mauricio Adade, President of Royal DSM in Latin America and Chairman of the Brazilian Association for Bioinnovation (ABBI), asserts a promising future where biorefineries may generate around $400 billion (USD) in investments in the next 20 years (see: https://www.linkedin.com/pulse/new-era-bioeconomy- brazil-mauricio-adade/). In this context, bioeconomy pertains to scientific knowledge advancement and technological innovation in the pursuit of new applications of biologically based industrial resources or processes.

When stepping into the bioeconomic realm, a company willing to invest in Research & Development (R&D) making use of Brazilian biodiversity must be aware of the legislation regulating the access to genetic resources and traditional knowledge associated.

Law # 13,123 of May 20, 2015 was enacted to be the new benchmark legislation, implementing in the country the Convention on Biological Diversity’s principles on access to genetic resources, traditional knowledge associated and the sharing of benefits therefrom. It seeks to solve the deadlock of the previous law, which was recognized for imposing severe burdens on R&D and, consequently, discouraging companies and even universities to further investigate the potential of Brazil’s biodiversity – only a few, such as the cosmetic company Natura, had a marketing campaign with a featured line of products deriving from it.

Abolishing the requirement of government’s authorization prior to the beginning of R&D activities, the current law establishes a self-registration system, in which biodiversity users inform about the access to the genetic resources or associated traditional knowledge prior to: (i) shipping of samples abroad with ownership transfer; (ii) applying for any intellectual property right; (iii) marketing of intermediate products; (iv) disclosure of partial or final results; or (v) notification of finished products or reproductive material developed as a result of access.

It is noteworthy that, under the legislation, access is defined as research or technological development carried out on a sample of the genetic resource or on associated traditional knowledge enabling access to the respective genetic resource. It relates to the R&D activities, including the use of digital sequence information, and not only to the physical samples.

The Ministry of Environment is responsible for implementing the legislation pertaining to the use of biodiversity within the Executive branch. Despite the current political uncertainties surrounding the political nominations for leading positions within the Ministry of Environment, compliance to the legal rules should not be disregarded and is imperative to avoid penalties that may jeopardize investments

Viviane Kunisawa is a partner at Licks Attorneys, leading the regulatory compliance team in life sciences, including the protection of regulatory data and access to biodiversity. She may be reached at viviane.kunisawa@lickslegal.com.