Following a long-waited ratification (on March 4, 2021), Brazil became a party to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (“Nagoya Protocol” or “Protocol”) on  June 2, 2021. This is an opportunity to dig into some practical consequences of the ratification. One of these consequences relates to offering a possible remedy to clarify one of the pending issues related to the material scope of Law 13123 of May 20, 2015 (the “Brazilian Biodiversity Law” or “Law”).

As a matter of fact, the Brazilian Biodiversity Law regulating the access to so-called Brazilian genetic heritage foresees a very broad scope for its application. So broad that materials that qualify as species native to Brazil may fall in the scope of the Law even if not having been sourced in Brazil. Lacking an exhaustive list of such native species and/or clear guidance from authorities on the limits of the scope of the Law, companies face uncertainties when handling materials that may incidentally fall in scope of the Brazilian Biodiversity Law, with the associated risk of non-compliance.

Brazilian genetic heritage is defined by the Brazilian Biodiversity Law as the information of genetic origin from plants, animals, microorganisms or other species: (i) found in in situ conditions; or (ii) kept in ex situ conditions, provided that they are also found in in situ conditions within the Brazilian territory, on the continental shelf, in the territorial sea, and in the exclusive economic zone. If the genetic heritage is found in in situ conditions, it exists within ecosystems and natural habitats. By contrast, a given species is found in ex situ conditions whenever it is kept outside its natural habitat.

Since there is not an exhaustive list of all the species considered Brazilian genetic heritage, in order to identify native species, one should consult recognized sources of scientific information, such as the Flora do Brasil  website.

As a general rule, activities (e.g. research, technological development, transfer of samples abroad, etc.) involving native species, whether endemic or not, regardless of where the species were cultivated or collected, fall within the scope of the Brazilian Biodiversity Law. In other words, regardless of the place of cultivation and/or collection, the classification as “native species” may result in it being subject to inspections under the Brazilian Biodiversity Law.

That means, for example, that a given plant may be considered in the scope of the Law despite not being harvested/cultivated in Brazil. Even in the hypothesis that the species has been cultivated in another country for a long time (sometimes for several centuries) and may have in the meantime developed some local characteristics may not be sufficient to place it out of the scope of the Law. In fact, unless it could be claimed that the differences in genetic characteristics could allow to consider the plant as another species, authorities may still consider it as found in situ in the meaning of the Brazilian Biodiversity Law.

The foregoing has far reaching consequences for companies seeking to determine whether or not materials they use in their products may fall in the scope of the Law—even if not sourced from Brazil—and consequently whether or not said companies may face not only registration obligations but also benefit-sharing obligations.

The consequence of Brazil becoming a party to the Nagoya Protocol

The ratification of the Nagoya Protocol may impact the situation described above, as some provisions of the Protocol may be used to narrow and/or circumvent the material scope of the Brazilian Biodiversity Law.

Indeed, Article 11(1) of the Nagoya Protocol states the following: “In instances where the same genetic resources are found  in situ within the territory of more than one Party, those Parties shall endeavor to cooperate, as appropriate, with the involvement of indigenous and local communities concerned, where applicable, with a view to implementing this Protocol.” This article, as well as article 10, intends to tackle the challenges associated with transboundary situations, in which addressing the fair and equitable sharing of benefits derived from the utilization of genetic resources may be difficult.

Therefore, and at least in situations where a given material would originate from another country that is also a party to the Nagoya Protocol, it is arguable that Brazilian authorities could not validly claim the applicability of the Brazilian Biodiversity Law even if such material qualifies as a native species found in situ in Brazil. This would constitute an important element to bring to the attention of Brazilian authorities if one were to verify whether or not a given situation would fall in the scope of the Brazilian Biodiversity Law.

This being said, it remains that companies may not draw direct rights from the abovementioned provisions of the Nagoya Protocol, given the absence of clear binding rules on the topic and the fact that the relevant authorities have not established an official position on situations similar to the one under discussion.

Hopefully, with the Nagoya Protocol entering into force for Brazil, we expect discussions on biodiversity to gain momentum in the country and, as a result, the Brazilian government to soon put into place regulations to promote transboundary cooperation and overall compliance with the Protocol.

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This article provides information and comments on legal issues and developments of interest. The foregoing is not a comprehensive treatment of the subject matter covered and is not intended to provide legal advice. Readers should seek specific legal advice before taking any action with respect to the matters discussed herein.