Nagoya Protocol - What is it?

The Nagoya Protocol is an international agreement that aims to achieve a fair and equitable sharing of benefits arising from the utilization of genetic resources (GR)  and / or from the utilization of traditional knowledge related to genetic resources (TKaGR).

It is a treaty under international law and implements the Access and Benefit-Sharing (ABS) obligations of the Convention on Biological Diversity (CBD). In Germany, it came into force on 12 October 2014.

Underlying definitions

Researchers around the world, and accordingly also at the University of Hohenheim, who utilize such resources in the course of their research are obliged to comply with certain rules of due care.

The Federal Agency for Nature Conservation (BfN) is the competent control authority for compliance with the Nagoya Protocol:

  • It has been conducting compliance checks since 2018.
  • It checks whether users have fulfilled their due diligence obligations.
  • It penalizes violations of EU Regulation no. 511/2014.
    Violations are administrative offenses and can result in fines of up to € 50,000 as well as the confiscation of the genetic material and mean the stop of data use and the research project!

Underlying laws and regulations:


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Commitments under the Nagoya Protocol

The three pillars

Both access and benefit-sharing obligations are established and negotiated between the provider country and the user of the genetic resource (GR).

Access and benefit-sharing obligations are regulated at the national level, i.e. according to the national laws of the country providing the genetic resource (GR). Each country can decide whether and how to regulate its genetic resources (GR).

Pillar 1

PIC: Prior Informed Consent

The provider country imposes access obligations on the person using the genetic resource (i.e.: the researcher) prior to the acquisition of this resource. These are usually written down in the form of a PIC (Prior Informed Consent) permit.

In each case, the provider country is the country in which the genetic resource (GR) is originally located and from which it is initially accessed.

Please contact the Research Support Department. We will support you in the application process.

Pillar 2

MAT: Mutually Agreed Terms

Benefit-sharing obligations are negotiated between the provider country of the genetic resource (GR) and the user of the genetic resource (GR), usually in the form of mutually agreed terms (MAT).

These MATs specify, among other things:

  • what monetary and / or non-monetary measures are taken to share the benefits,
  • what can be done with the genetic resource (GR) (i.e., commercial or non-commercial research),
  • who will use the resource,
  • how long the use may take place,
  • whether the resource can be shared with other scientists.

Once the user of a genetic resource (GR) obtains a PIC (consent to use) and a MAT (contractual agreement of access terms) from the provider country of the genetic resource (GR), the provider country may issue an Internationally Recognized Certificate of Compliance (IRCC) to demonstrate the legality of the access and the establishment of the MATs.

Please contact the Research Support Department. We will support you in the application process.

Pillar 3

Compliance: EU ABS Regulation

Compliance obligations are implemented and regulated in Germany in accordance with EU ABS Regulation No. 511/2014.

They also include, in particular, measures to monitor the use of genetic resources at defined control points (e.g., research and/or development phase, pre-commercialization, or commercialization phase) and  to document the conservation and use of resources.

The documentation obligation lies with the respective users of the individual resources; assistance is provided by the internal documentation guide (English version).

In Germany, the Federal Agency for Nature Conservation (BfN) is responsible for monitoring compliance with EU regulations.

The Nagoya Protocol at the University of Hohenheim

The University has adopted the following documents to implement the provisions of the Nagoya Protocol as a guideline for access to and management of genetic resources (GR) and traditional knowledge related to genetic resources (TKaGR) for its scientists:

 

Quick navigation: During application / project planning  |  During the project |  After completion of the project

 

 

During application / project planning

The Nagoya Protocol must be considered and included when applying for a project. This is the only way to ensure that funds are available for any benefit sharing.

How do I ensure that I can use the genetic resource / the traditional knowledge related to it in a legally compliant manner?

This is possible in two ways:

  • with an Internationally Recognized Certificate of Compliance (IRCC) or, if such a certificate is not available,
  • with a PIC (prior informed consent) and MAT (mutually agreed terms), if applicable.

Where can I get PIC and MAT?

PIC (prior informed consent) and MAT (mutually agreed terms) are negotiated with the country granting access.

You will be supported by the lawyers who work in the Research Support Department.

How long does it take to get PIC or MAT?

There is some experience with this, which you can find in the ABS stories of the German Nagoya Protocol Hub.

As the negotiation of PIC (consent to use) and MAT (contractual agreement on access conditions) is carried out with representatives of the country providing the genetic resource (GR)/traditional knowledge related to it (TKaGR), a longer negotiation period is often to be expected.

Where can I find information about the Internationally Recognized Certificates of Compliance (IRCC)?

Information can be found on the Access and Benefit-Sharing Clearing-House platform.

Where can I find contacts in the country of access?

For a country-specific list of contacts, visit the Access and Benefit-Sharing Clearinghouse platform.

Do I need to draw on a genetic resource / the traditional knowledge related to it in my research project?

No. If it is possible for you to use a genetic resource and / or traditional knowledge that is not within the scope of the Nagoya Protocol or for which approval procedures have been established by the providing country, such use is recommended.

Information and support services for project planning

Checklist from the German Nagoya Protocol HuB

Checklist from the German Nagoya Protocol HuB

The checklist "Build your ABS Strategy" from the German Nagoya Protocol HuB is intended to help academic researchers in Germany who are new to the field of Access and Benefit-Sharing (ABS).

It highlights some of the key things researchers need to consider when preparing for the process and consists of four sections:

  • Preparatory steps, e.g., get informed, clarify formalities, and find help
  • Establishing the "red line" for negotiations, i.e., identifying those aspects of a research project that are essential and must be covered by your ABS documentation
  • Working out what types of benefits can be shared
  • Exploring options for future research (after the current research project ends)

ABS Clearing House

ABS Clearing House


The ABS Clearing House website offers important information on an international level for practical work.

All contact details of the Nagoya Protocol partner countries and also the status of each country regarding the implementation of the Nagoya Protocol rules are available on this website.

Federal Agency for Nature Conservation

Federal Agency for Nature Conservation

The Federal Agency for Nature Conservation (BfN) is the German authority responsible for the implementation of the Nagoya Protocol and EU Regulation 511/2014 and is thus also the contact and advisory body for all users as well as collections in Germany.

The website of the Federal Agency for Nature Conservation offers helpful information on this:
BfN information flyer on the Nagoya Protocol
BfN recommendations for action on EU Regulation No. 511/2014 - 10 steps to compliance for users

German Research Foundation (DFG)

 

During the project

According to the requirements of the Nagoya Protocol, there are due  diligence, reporting (to the Federal Agency for Nature Conservation as the national control body) and documentation obligations (regarding compliance with due diligence).

What is a due diligence statement?

The due diligence declaration is a necessary documentation of compliance with the due diligence obligations arising from the Nagoya Protocol. In the case of research funded by third parties, it is due after receipt of the grant and, if necessary, again in the context of the exploitation of the results.

Where can I find the template for a due diligence declaration (Annex II of the Implementing Regulation)?

For the due diligence declaration, the questions must be answered in accordance with the model set out in Annex II to Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015.

Where do I submit the due diligence declaration?

It is recommended that the declaration of due diligence be submitted electronically to the Federal Agency for Nature Conservation (BfN) via its DECLARE Internet portal. 

In addition, it must be stored in the documentation software of the University of Hohenheim. If you have further questions, please contact the Research Support Department.

Do I have to submit the due diligence declaration for collaborative projects as well?

Yes. Please inform the coordinator accordingly.

What do I need to consider for an invention made using the genetic resource/traditional knowledge?

Evidence of the Internationally Recognized Certificates of Compliance (IPCC) or PIC and MAT must be submitted with the patent application.

Please contact the Research Support Department.

 

After completion of the project

  • Relevant information for access and benefit sharing must be retained for 20 years after the end of the period of use. These are:

    • Internationally Recognized Certificate of Compliance (IRCC) or
    • PIC (prior informed consent) and MAT (mutually agreed terms)
    • Due diligence declaration

  • For first-time commercial use of project results, an additional due diligence declaration (Appendix III of the Implementing Ordinance) must be submitted. First-time commercial use includes

    • either the market authorization or approval, or the placing of a product on the market or sale of the results of its use within the EU.
    • the completion of the exploitation of genetic resources and / or traditional knowledge related to them within the EU and transfer / sale of the results to persons outside the EU.

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What are “genetic resources” (GRs)?

A Genetic Resource (GR) is all genetic material of any living organism (plant, animal, microbial, or other (non-human) origin) containing functional units of heredity, or derivatives of a genetic resource (e.g., enzymes, proteins, metabolites) with actual or potential value (definition from the Convention on Biological Diversity, Nagoya Protocol and EU Regulation No. 511/2014).

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What does "traditional knowledge associated with genetic resources" (TKaGR) mean?

There is currently no accepted definition of "traditional knowledge associated with genetic resources" (TKaGR) at the international level. It can be considered knowledge, innovations, skills, and practices developed, maintained, and passed on from generation to generation within a community and in a traditional context.

The EU regulation defines TKaGR as traditional knowledge of an indigenous or local community that is relevant to the use of genetic resources and is described as such in the mutually agreed terms and conditions for the use of genetic resources.

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What does “utilization” of genetic resources mean?

Utilization means conducting research and/or development activities on the genetic and/or biochemical composition of these resources or their derivatives.

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Who is considered a "user" of genetic resources (GRs)?

Direct users are researchers who obtain the resource directly from the provider country.

You are considered an indirect user either if you obtain the resource from a third party such as a collaboration partner, registered/private collection, etc. ("indirect incoming")or if you hand over the resource to a third party e.g., a collaboration partner ("indirect outgoing").

As a direct or indirect user of GR or TKaGR (traditional knowledge associated with genetic resources), you are required to exercise due diligence and to make a due diligence declaration in order to comply with the EU ABS Regulation.

They must ensure that genetic resources have been accessed in accordance with the applicable access and benefit-sharing laws of the provider country and, where appropriate, that benefit-sharing measures have been established.

It is your responsibility as a user of genetic resources to locate, retain, and pass on all proper records to subsequent users.

IMPORTANT! It is your responsibility as a user of genetic resources to stop using them if there is not enough information about the legality of the access.

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