What’s Next After Brazil’s Enactment of the Nagoya Protocol

by | Apr 10, 2024 | Articles, Life Sciences, Regulatory

“Promulgation was the final step that was missing for [the Nagoya Protocol’s] formal incorporation into the national legal system. However, there remains a need to establish mechanisms for compliance with foreign laws or national legislation at the international level, which include ‘checkpoints.’”

In a significant milestone for the preservation of biodiversity, Decree 11,865/2023, published in the Official Gazette on 12/28/2023, enacted the Nagoya Protocol in Brazil. The protocol, providing for access to genetic resources and the fair sharing of benefits arising from their use, is part of the renowned Convention on Biological Diversity (CBD).

The Nagoya Protocol, in force since October 12, 2014, relates to the international commitment of 140 countries, including Brazil, to implement the objective of the CBD on the fair and equitable sharing of benefits from the use of genetic resources and the traditional knowledge associated with them (TK).

Implications of the Nagoya Protocol on Access to Genetic Resources and Benefit Sharing in Brazil

The Protocol considers the principle established by the CBD that countries have sovereign rights over genetic resources on their territory and may require compliance with requirements and sharing of benefits arising from their use by individuals, companies or government entities in other member countries. Thus, the parties to the Protocol, whether they are a provider or user country, must ensure that access to these genetic resources and TK, as well as the sharing of benefits arising from their use, are in accordance with the legislation of the respective countries of origin.

Brazilian law (Law 13.123/2015) determines that activities of access to the national genetic heritage and TK must be registered in the National System for the Management of Genetic Heritage (SISGEN). Access, in turn, is defined as research or technological development carried out on a genetic heritage sample or TK. The sharing of benefits will occur in the case of economic exploitation of a finished product (i.e. the one made available to the final consumer, not requiring an additional production process, and in which the element of biodiversity or TK is one of the main elements of value addition) or reproductive material from this access.

According to the rules of the Protocol, there is a general duty for foreign industry to also comply with Brazilian legislation when accessing the genetic resources of the country’s biodiversity or TK for the development and manufacture of products, even if located outside Brazilian territory. If such legislation had already been in force at the time, it would have applied, for example, to the case involving the venom of the Jararaca snake used for the development of the drug Captopril, and the use of the essential oil of the rosewood tree native to the Amazon for Chanel N°5. As a result, we can see that the Protocol has the potential to mitigate regulatory asymmetries between domestic and international companies.

On the other hand, the impacts on domestic industry resulting from the ratification of the Protocol are mainly related to the general duty to understand and comply with the obligations established by the country providing a foreign genetic resource or TK. When developing a new product that makes use of foreign biodiversity, the Brazilian company must be aware of the legislation of the country of origin and comply with its requirements for access and benefit sharing.

One of the main concerns during the ratification process of this international treaty was related to the use of originally foreign species in agriculture and livestock. Despite its rich wild flora and fauna, the species cultivated and raised for food have been mostly introduced into the country. In terms of commodities for export or food for domestic consumption, such as soybeans, cattle, and rice, this has generated apprehension about the potential for rural producers to be required to pay for their use.

In this context, it is important to note that the Brazilian law on access to biodiversity, Law 13.123/2015, establishes that the sharing of benefits provided for in the Protocol should not apply to the use of species introduced into the country by human action in activities related to agriculture and livestock before its entry into force. This proviso is contained in the promulgating decree as a special condition provided for in Article 8(c) of the Protocol.

Thus, Brazil has implemented a restriction on the scope of the Protocol in its national legislation, looking to mitigate its impact in this area.

Future Challenges

Promulgation was the final step that was missing for the Protocol’s formal incorporation into the national legal system. On 03/04/2021, Brazil deposited a letter with the United Nations ratifying the Protocol, which had been approved by the Senate the previous year.

However, its effective application is not yet possible, as there is a need to establish mechanisms for compliance with foreign laws or national legislation at the international level, which include “checkpoints”. For example, the Brazilian Patent and Trademark Office (BPTO) currently only investigates whether Brazilian law has been complied with in the development of inventions that use associated national genetic heritage or traditional knowledge. It does not examine the matter from the perspective of foreign laws and their respective biodiversity.

The need for multilateral measures to achieve the objectives of the Protocol is currently being discussed among the member countries due to the difficulties of its implementation in practice. The costs of monitoring and complying with the legislation of the different countries by the various industries may surpass the incentive of research and innovation from the use of the elements of biodiversity and, thus, not generate benefits to be shared with local communities.

Final Remarks

Although multilateral measures are being discussed among the member countries to achieve the objectives of the Protocol, due to the difficulties of its implementation in practice, it will be necessary to implement processes and structures so that Brazil can fulfill the obligations it has assumed before the international community. All of this must also be considered within a context of valuing biodiversity and recognizing the need for its preservation and sustainable use, as enshrined in the Kunming-Montreal Global Framework for Biological Diversity, and in view of the expectation of international negotiations for a new treaty on disclosure of the origin of genetic resources and TK within the scope of the World Intellectual Property Organization (WIPO).

Article published on IPWATCHDOG

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