On March 4, 2021, Brazil deposited with the United Nations its ratification of the Nagoya Protocol (“Protocol”) (see here the announcement of Brazil’s Ministry of Foreign Affairs).  This represents Brazil’s formal commitment to be bound by the Protocol.

On August 6, 2020, the Brazilian Senate passed a Decree that ratifies the Nagoya Protocol. The Protocol complements Brazil’s existing access and benefit sharing rules relating to Brazil’s genetic heritage and associated traditional knowledge (“ABS Framework”).  One important effect of this ratification is that other countries parties to the Protocol will have to ensure that users of Brazilian genetic heritage and associated traditional knowledge comply with the Brazilian ABS Framework.  However, the inverse is also true.  Brazil will need to ensure that Brazilian users of foreign genetic heritage and associated traditional knowledge comply with the access and benefit sharing regime of the country of origin.

Brazil’s Existing ABS Framework

Brazil’s current ABS Framework can be found in Law no. 13.123, of May 20, 2015, and Decree no. 8.772, of May 11, 2016.  These laws apply to research and development (“R&D”) conducted on Brazilian genetic heritage and/or associated traditional knowledge after the entry into effect of Law 13.123, on November 16, 2015 and, retroactively, to R&D conducted on Brazilian genetic heritage or associated traditional knowledge in scope of the law that was in place prior to Law 13.123 (i.e., Provisional Measure 2.186, of August 23, 2001, which superseded Provisional Measure 2.052-1, of June 29 2000).

Even though Law 13.123 entered into force on November 17, 2015, some of its articles required implementation through secondary legislation.  The Brazilian Government has issued in the past 3 years various ordinances implementing the law (accessible here).  For example, on April 23, 2020, the Brazilian Government published Ordinance no. 199, which regulates the measures that non-Brazilian entities must put in place to bring their R&D activities conducted between June 30, 2000 and November 16, 2015 in compliance with Law 13.123.  These measures include signing terms of commitment with the Secretory of Biodiversity of the Brazilian Ministry of the Environment and entering into a partnership with a Brazilian public or private scientific and technological research institute.  Non-Brazilian entities that take these measures will not be subject to enforcement for the R&D they conducted in disregard with the Provisional Measures.

Some of the Effects of Brazil’s Ratification of the Protocol

Brazil’s ratification of the Protocol will allow it to actively participate in discussions on the issues regarding the implementation of the Protocol, such as the 15th UN Biodiversity Conference 2020 which was postponed to May 2021 due to COVID-19.

Users that are established in the European Union, Switzerland, Korea or Japan, should now ensure that they comply with the local compliance mechanisms in those jurisdictions.  The Nagoya Protocol requires that all countries that are parties implement mechanisms to ensure that the ABS rules of the other members of the other members are complied with.  Brazil is well known for its expansive ABS laws (e.g. they include digital sequence information, or references to Brazilian genetic heritage on products can already trigger the ABS laws), but were beyond the scope of those compliance mechanisms.  The ratification of the Protocol has changed this.

Relationship Between the Brazilian Current ABS Framework and the Protocol

The Decree that ratifies the Protocol provides that the Brazil’s existing ABS Framework implements the Protocol in Brazil.

The Decree exempts from the Protocol’s benefit sharing regime the economic exploitation for the purpose of agricultural activities of reproductive material of species introduced into Brazil by human action before the entry into force of the Protocol (on October 12, 2014).  This means that it will not recognize benefit-sharing claims from other Protocol members relating to species introduced in Brazil before that date.  This exemption was introduced in order to obtain the support of the Brazilian agricultural parties (bancada ruralista), which was necessary to obtain a majority voting and pass the Decree that ratifies the Protocol.

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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart…

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart holds a Ph.D. in EU and International Law and was a professor of EU law until 2013. During that time, he wrote the first-ever handbook with Cambridge University Press on “EU External Relations Law” (2014). He then transitioned to private practice, and frequently acted for the Belgian government before the EU Court of Justice (e.g. C-16/16P Belgium vs Commission). Bart joined Covington in 2016, leading some of our most consequential EU litigation proceedings (e.g. C-311/18 “Schrems II”) over the years.  Having handled nearly 50 cases before the EU Court, he’s uniquely qualified to support our corporate clients in our most high-stakes disputes. Recent examples include T-189/21 Aloe Vera of Europe v Commission (which we won, so the Commission decided to appeal); as well as T-201/21 Covington & Burling and Van Vooren v Commission (which we also won, and hence is also on appeal).

As a pioneer in biodiversity law, over the past 15 years Bart has built a unique, global practice on Access and Benefit-Sharing (ABS) laws under the Convention on Biological Diversity, the Nagoya Protocol, the Plant Treaty, the High Seas Treaty and the WHO Pandemic Agreement. ABS compliance is critical when sourcing biological materials for life sciences R&D and I work with many of the world’s innovative life sciences companies on the whole range of e.g. transactional, contractual, compliance, IP, (EU) regulatory and litigation work relating to ABS. As biodiversity has increasingly become identified as a major commercial and financial risk to companies, so has the practice expanded to e.g. biodiversity credit markets, biodiversity insurance, biodiversity claims and advertising, and so on. Since April 2025, Bart has been appointed as the industry representative to the Steering Committee of the UN Biodiversity Fund that seeks funding from the private sector for biodiversity conservation and restoration.

Bart also pioneered our global health practice. He has advised pharmaceutical clients on seasonal and pandemic influenza since 2016. Since then, this practice area expanded to cover all matters relating to infectious diseases, and as of 2020, emergency preparedness and response (eg. WHO prequalification, International Coordination Group negotiations, Emergency Use Listing, International Health Regulations Rev 2024). He has been the pharmaceutical industry’s lead lawyer advising on the WHO Pandemic Treaty negotiations, adopted on 14 May 2025. Currently, he continues to advise on the work of the Intergovernmental Working Group (“IGWG”) teasing out the technical details of the “Pathogen Access and Benefit-Sharing System” intended to create legally binding obligations on companies to commit vaccines, therapeutics and diagnostics in case of a new global health emergency.

In Chambers rankings, clients have kindly described Bart as “very knowledgeable, action-focused and service-focused lawyer”, adding that he “really tries to find a way of working through challenges”, am “customer-oriented” and provide “sound advice and reasonable options for our business with pros and cons.”

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation before the EU Court.

Photo of Anna Sophia Oberschelp de Meneses Anna Sophia Oberschelp de Meneses

Anna Sophia Oberschelp de Meneses is special counsel in the Data Privacy and Cybersecurity Practice Group.

Anna is a qualified Portuguese lawyer, but is both a native Portuguese and German speaker.

Anna advises companies on European data protection law and helps clients coordinate…

Anna Sophia Oberschelp de Meneses is special counsel in the Data Privacy and Cybersecurity Practice Group.

Anna is a qualified Portuguese lawyer, but is both a native Portuguese and German speaker.

Anna advises companies on European data protection law and helps clients coordinate international data protection law projects.

She has obtained a certificate for “corporate data protection officer” by the German Association for Data Protection and Data Security (“Gesellschaft für Datenschutz und Datensicherheit e.V.”). She is also Certified Information Privacy Professional Europe (CIPPE/EU) by the International Association of Privacy Professionals (IAPP).

Anna also advises companies in the field of EU consumer law and has been closely tracking the developments in this area.

Her extensive language skills allow her to monitor developments and help clients tackle EU Data Privacy, Cybersecurity and Consumer Law issues in various EU and ROW jurisdictions.