The Nagoya Protocol on Access and Benefit-Sharing (ABS) was concluded at the 10th Conference of the Parties to the Convention on Biological Diversity in 2010 and regulates access to genetic resources and the fair and equitable sharing of the benefits arising from their utilization. Researchers at Kiel University whose research falls within the scope of the EU ABS Regulation (EU) No. 511/2014 are required to submit a due diligence declaration. In Germany, violations to the EU ABS Regulation can constitute an administrative offence and can be subject to fines of up to € 50,000.
On this page you will find more information on what the Nagoya Protocol is, how to assess if your research falls within the scope of the EU ABS regulation and how to comply with potential obligations.
The Nagoya Protocol on Access and Benefit-Sharing (ABS) is an international agreement that aims at the fair and equitable sharing of benefits arising from the utilization (research and/or development) of genetic resources (and/or traditional knowledge associated to them).
Within national jurisdiction, including the 200 nm of exclusive economic zone and extended continental shelf (if any), the Nagoya Protocol covers all genetic resources (i.e. material that contains DNA/RNA, dead or alive, and its derivatives) and its utilization. It excludes human DNA but human pathogens and human-associated microorganisms (human microbiome) might be covered under certain countries and conditions. The Nagoya Protocol excludes organisms[MOU2] covered by specialized treaties (e.g. International Treaty on Plant Genetic Resources for Food and Agriculture and Pandemic Influenza Preparedness) that are used under the terms of those agreements.
A genetic resource is defined (in the Convention on Biological Diversity, Nagoya Protocol and EU ABS regulation Nr. 511/2014) as any material of plant, animal, microbial or other (non-human) origin containing functional units of heredity which has actual or potential value, or derivatives of a genetic resource (e.g. enzymes, proteins, metabolites).
Utilization is defined as conducting research and/or development on the genetic and/or biochemical composition, or derivatives, of these resources.
Fostering compliance to the Nagoya Protocol requires an understanding of its pillars: Access, Benefit-Sharing and Compliance obligations (ABCs of ABS).
I. Access obligations (PIC - Prior Informed Consent)
Access obligations, usually in the form of a Prior Informed Consent (PIC) permit, will be granted by the Provider Country of the genetic resource to the user (i.e. researcher) of the genetic resource prior to the acquisition of such resource. The Providing Country refers to the Country where the genetic resource is found in situ and where it will be initially accessed from.
II. Benefit Sharing (MAT – Mutually Agreed Terms)
Benefit-Sharing obligations, usually in the form of Mutually Agreed Terms (MAT), are contractual obligations between the Providing Country of the genetic resource and the user of the genetic resource. MATs will establish monetary and/or non-monetary benefit-sharing measures and also establish what can be done (i.e. commercial or non-commercial research) with the genetic resource, who will be the user of such resource, for how long, if the resources can be transferred to other scientists, etc.
Once the user of a genetic resource obtains a PIC and a MAT from the Providing Country of the genetic resource, the Providing Country might extend an Internationally Recognized Certificate of Compliance (IRCC) to show the legality of access and the establishment of MATs and can decide to publish it on the ABS Clearing House website. The ABS Clearing house website was established to support the implementation of the Nagoya Protocol and provide transparency and legal certainty with regards to ABS regulations in providing countries of genetic resources.
Both Access and Benefit-Sharing obligations will be established and negotiated between the Providing Country of the genetic resource and the user of the genetic resource. Access and Benefit-Sharing obligations are regulated at a national level, that is, regulated under national laws of the Country providing the genetic resource. Each Country can decide if and how they regulate their genetic resources.
III. Compliance obligations
Compliance obligations, on the other hand, are implemented and regulated in Germany by means of the EU ABS regulation No.511/2014. Compliance obligations are laws, administrative tools or policy instruments that Nagoya Protocol parties have to establish in order to ensure that whenever research and/or development on genetic resources takes place within their jurisdiction, the researchers comply with ABS rules/obligations of the Country where the genetic resource was accessed from. It also includes measures to monitor the utilization of these genetic resources at designated check-points (e.g. research and/or development phase, pre-commercialization or commercialization phases).
As a user (direct or indirect) of genetic resources (and/or traditional knowledge associated to them) ) you are obliged to exercise due diligence and submit a due diligence declaration to comply with the EU ABS regulation. This means, you ensure that the genetic resources have been accessed in accordance to applicable access and benefit-sharing legislation from the Country of origin and, if applicable, benefit-sharing measures have been established. Therefore, as user of genetic resources, it is your responsibility to seek, keep and transfer all proper documentation to subsequent users. You need to keep documentation (PIC and MAT, if available) of the legality of access to the genetic resources for a period of 20 years after the end of utilization. This only applies to documents and not the storing of the physical sample.
You are a direct user when you obtain/collect the resource directly from the country of origin. As a direct user, it is your responsibility to ensure that you can collect and use the material according to the country of origin applicable ABS laws and that you are allowed to transfer the material to third parties, if yes, you should transfer all relevant information with the material to the next user.
You are an indirect user, when your resource is obtained from a third party such as a collaborator, registered/private collection, company, etc. As an indirect user, it is your responsibility to ask for information or documentation about the legal acquisition of the resource you want to work with.
Note: It is your responsibility as a user of genetic resources to discontinue utilization if there is insufficient information on the legality of its access.
For direct users of genetic resources
You can use this checklist (pdf) to determine if your research falls within the scope of the EU ABS regulation. If you check “YES” in ALL categories you will be obliged to exercise due diligence (i.e. seek, keep and transfer relevant documentation)and file a due diligence declaration.
The due diligence declaration has to be submitted when a public or privately funded research project has been granted (i.e. between receiving the first instalment of funding as well as collecting all genetic resources to be used in the project or before the end of project) and at the final stage of product development, if any (i.e. commercialization including the sale of research results). As a user (i.e. Researcher) of a genetic resource, you will be liable if found non-compliant with the regulation. The submission of a due diligence declaration through the EU DECLARE portal will be supported by the Nagoya Protocol Compliance Officer at Kiel University and consists of the submission of all relevant documents proving the legality of access (i.e. PIC, MAT or IRCCs) and general information of the project associated with it.
Even if you are not obliged to submit a due diligence declaration, you still have to obey national ABS regulations of the Providing Country of the genetic resources.For example, Costa Rica is not party to the Nagoya Protocol and thus you would not be obliged to submit a due diligence declaration. However, Costa Rica has national ABS legislation since 1998 that you will have to obey in order to access and utilize their genetic resources. If you are not sure which ABS rules apply in your case, you can contact the National Focal Point (NFP) of the Providing Country of the genetic resources listed on the ABS Clearing House website or the Nagoya Protocol Compliance Officer at Kiel University for assistance.
For indirect-incoming and indirect-outgoing users of genetic resources
If you transfer (i.e. indirect-outgoing) genetic material to another user outside of the University for further analyses, you will need to do so through a Material Transfer Agreement (MTA-outgoing) form. If MATs measures have been established for the resources you are transferring, an MTA will ensure that the next user will continue utilizing the resource only under the initial terms and conditions established in the PIC/MATs by the Providing Country of the genetic resources. If a change of intent on the utilization of the genetic resource is envisioned (e.g. from non-commercial to commercial research), then the initial PIC and MATs will have to be renegotiated with the Providing Country of the genetic resource.
This also applies if you are receiving (i.e. indirect-incoming) the genetic material from another user. You need to ensure, as part of your due diligence obligation, that if you are receiving genetic material from a collaborating institute, they can provide documentation of the legality of access to those resources (i.e. PIC and MATs, if available). If you are receiving material from a collaborator/external source, do so through an MTA-incoming form.
The signing of the MTA-outgoing by Kiel University is carried out by legal representation of Kiel University (through the Nagoya Protocol office) and the user of the genetic resources (i.e. Researcher). Any changes in the content of the MTA must be coordinated and approved by the Nagoya Protocol Compliance Officer at Kiel University.
In Germany, compliance checks started in 2018. Compliance-checks are conducted by the Competent National Authority (in Germany: the Federal Agency for Nature Conservation) of the Country where the access and utilization of the resource will take place to control if users of genetic resources have fulfilled due diligence obligations.
Authorities in Germany already imposed the first regulatory offense in 2021 to a University found non-compliant with the EU ABS regulation. These fines can amount of up to 50,000 EUR depending on the severity of the infringement. Furthermore, the genetic material can be seized/confiscated and utilization stopped (i.e. research project). In Countries like Brazil and India researchers have gone to jail for violating national laws. Malaysia might decide to ban a group of researchers from entering the Country after not being able to prove they legally acquired a new species of tarantula which they recently published on a peer-reviewed journal.
In case of questions or concerns, you can email the Nagoya Protocol Compliance Officer at Kiel University.