The Nagoya Protocol
The Nagoya Protocol - An International Agreement
The "Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization [...]" entered into force on 12 October 2014. This international agreement is relevant for all scientists working with biological material and/or related traditional knowledge that originates from outside Germany (see below for definition).
The University of Bremen recognizes the importance of complying with the Nagoya Protocol. The Nagoya Compliance Officer provides support for its implementation and helps all scientists to understand and comply with their obligations under the Nagoya-Protocol and the EU ABS Regulation.
It is important to respect both the regulations in the countries providing the genetic resource and the regulations at EU level!
The National Implementation in the Provider Country
In order to comply with the provisions of the Nagoya Protocol, the national jurisdiction of the country providing the genetic resource must be followed. Access and Benefit-Sharing (ABS) to genetic resources are governed by this national scope of the Nagoya Protocol.
The so-called Provider Countries are entitled to make access to their genetic resources subject to certain conditions. They can demand "fair and equitable sharing of the benefits arising out of the utilization of genetic resources". In some Provider Countries, scientists have been imprisoned for violating national ABS laws.
Users of material that falls under national jurisdiction according to the Nagoya Protocol are required to obtain from the Provider Country of the genetic resource the following documents, to retain them and to transfer them to subsequent users:
- "Prior Informed Consent" (PIC)
- "Mutually Agreed Terms" (MAT) (where appropriate)
The EU ABS Regulation for Implementation in the EU
The Regulation (EU) No. 511/2014 governs the implementation of the Nagoya Protocol obligations in the EU. All research projects that have obtained access to genetic resources (and/or traditional knowledge) and fall within the scope of the Nagoya Protocol, according to the jurisdiction of the Provider Country, are obliged to comply with the EU ABS Regulation.
Scientists are obligated to exercise due diligence and have a duty of explanation and cooperation in the event of an inspection by the national authority for the implementation of the Nagoya Protocol, the Federal Agency for Nature Conservation. In addition, the recipients of research funds are required to submit a Declaration of Due Diligence during the funding phase of the research.
If the research/utilization (as a non-commercial laboratory analysis) is being conducted in Germany, the EU ABS Regulation also applies to research projects carried out jointly with partners from third countries. Whenever scientists are involved as co-authors, they are considered users in the sense of the EU ABS Regulation.
In Germany, violations of Regulation (EU) No. 511/2014 constitute regulatory offences and can result in fines of up to €50,000, confiscation of the material and suspension of the research project.
Checklist Nagoya Protocol
This list provides an initial overview of whether a research project or material falls under the scope of the Nagoya Protocol and the EU ABS Regulation.File name: Checklist_Nagoya-Protocol_online.pdfLast update: 16.05.2023
Draft Email for National Focal Points
This draft email can be used for an initial request to the National Focal Point of the Provider Country. However, it is advisable to consult the Nagoya Compliance Officer first.File name: NFPdraftemail.docxLast update: 17.03.2023
"Material of plant, animal, microbial or other (non-human) origin containing functional units of heredity (e.g. DNA/RNA, dead or alive, including their derivatives such as proteins, enzymes, metabolites, etc.) and/or related traditional knowledge" (Definition from the Convention on Biological Diversity, the Nagoya Protocol and EU ABS Regulation No. 511/2014).
For more information on whether your material falls under the scope of the Nagoya Protocol, see the EU Guidance Document on the right and the Checklist Nagoya Protocol.
Nagoya Protocol Compliance Officer
Administrative Unit 12 – Research and Early-Career Researchers
University of Bremen
Phone: +49 421 218 57112
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07 June 2023 is the "Research Data Day"
The Nagoya Protocol will be discussed in the following workshop:
WS18: Datenmanagementpläne und Nagoya-Protokoll – Unterstützungsangebote und Rahmenbedingungen an der Universität Bremen (in german)
Venue: SFG, Room 3190, Enrique-Schmidt-Str. 7, 28359 Bremen, Germany
Duration: 11:30 to 13:00 hrs
Registration by e-mail to Björn Oliver Schmidt
Further information: https://www.bremen-research.de/tag-der-forschungsdaten/programm
Helpful Websites and Documents
Federal Agency for Nature Conservation
The German Federal Agency for Nature Conservation provides a good overview of the implementation of the Nagoya Protocol in Germany and the EU, as well as legal issues (in German).
Access and Benefit-Sharing Clearing House
The platform of the Convention on Biological Diversity provides information on all Parties to the Nagoya Protocol on the Access and Benefit-Sharing Clearing House and lists the respective National Focal Points (NFP).
Online portal to EU law EUR-Lex
This EU guidance document provides an overview of the scope and core obligations of the Regulation (EU) No. 511/2014, and when genetic resources are considered to be utilized under the EU ABS Regulation.
German Nagoya Protocol HuB
The German Nagoya Protocol HuB provides a platform with a very good overview of the Nagoya Protocol and Access and Benefit-Sharing for scientists as well as a contact point for questions. In addition, practical experiences on the Access and Benefit-Sharing process in different countries are exchanged.