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in scope of the law that was in place prior to Law 13.123 (i.e., Provisional Measure 2.186, of August 23, 2001, which superseded Provisional Measure 2.052-1, of June 29 2000).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.

Print:
EmailTweetLikeLinkedIn
Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Mr. Van Vooren has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.