Nagoya Protocol - Research with Genetic Resources

The Nagoya Protocol was adopted at the 10th Conference of the Parties to the UN Convention on Biological Diversity in order to ensure the fair and equitable sharing of benefits arising from the utilization (including research) of genetic resources. The aim is to reconcile the interests of the countries of origin of the resources on the one hand and the countries in which the resources are utilized on the other. The common term for this is “Access and Benefit Sharing”, abbreviated to ABS.

Another goal of the agreement is the conservation and sustainable use of biodiversity.

If the provider country is a party to the CBD (and the Nagoya Protocol), it can, in accordance with the Nagoya Protocol, make access to its resource dependent on the consent of the national competent authority (so-called Prior Informed Consent, PIC), as well as make access to and use of the resource dependent on mutually agreed terms (so-called Mutually Agreed Terms, MAT), in which the provider country's claim to equitable benefit-sharing from the use must also be taken into account. With the Nagoya Protocol (in force since 2014), the Parties to the Convention on Biological Diversity have agreed more precise regulations on the ABS system and, in particular, have undertaken to support the provider countries in enforcing their rights.

Scientists conducting research on non-human genetic resources or traditional knowledge associated with them must be familiar with the Nagoya Protocol. “Genetic resources” are defined in this context as genetic material of actual or potential value as long as it is of plant, animal, microbial or other origin and contains functional units of heredity. This includes, for example, animals and plants or parts of them, seeds, seedlings, fungi, bacteria and other unicellular organisms, as well as cell cultures, sperm, egg cells, chromosomes and DNA.

There are two fundamental aspects to consider when it comes to access and benefit sharing (ABS):

• the laws of the country from which the material originates and which regulate access and benefit-sharing
• the laws governing due diligence obligations under the Nagoya Protocol in the European Union

You must check whether the provider country has enacted ABS laws and whether these laws apply to you. It is mandatory to comply with the relevant requirements of the provider country, which may require special official approvals from the competent authorities there as well as specific contractual provisions.

Compliance obligations in the EU may exist in addition to the ABS obligations in the provider country. Check whether you have additional obligations in the European Union and whether you need to submit a due diligence declaration.

Human genetic resources are not covered by the Protocol.

If Access and Benefit-Sharing (ABS) laws apply to the material you wish to use for your research, you must obtain the necessary ABS documentation.

This may mean that you have to apply for authorization (prior declaration of consent) directly in the country providing the material and sign a benefit-sharing agreement.

If you receive the material from a third party - a collection, a commercial source, other researchers or a local collaborator - ask this person to provide you with a copy of the ABS documents and check whether these documents cover your planned research. If not, you may need to approach the providing country and organize the necessary documents.

The German Nagoya Protocol HuB provides a checklist of some of the most important things to consider.

In addition, you must check whether you have compliance obligations in Germany. This is determined by EU law, i.e. Regulation (EU) No. 511/2014. The regulation only applies if the material originally comes from a country that was a member of the Nagoya Protocol at the time of collection.

The German Nagoya Protocol HuB provides useful information on whether you have compliance obligations in Germany.

If Regulation (EU) No. 511/2014 applies to you, you are subject to due diligence obligations. These compliance obligations apply in addition to the ABS obligations in the country that provided the material.

This applies to you:

• Find, store and pass on information on ABS
• Submit a declaration of due diligence
• Support user controls by the German authority

In Germany, the due diligence declaration is received by the Federal Agency for Nature Conservation (BfN). The information in this declaration is then transmitted to the ABS Clearing House (provided the information is not confidential).

The Geman Nagoya Protocol HuB provides useful information about your obligations.

Even if the country is not a party to the Nagoya Protocol, you may need to obtain prior informed consent and sign a benefit-sharing agreement in order to legally use material for research. Some countries have ABS laws without having ratified the Nagoya Protocol, e.g. Costa Rica and Australia. You must always check national requirements before obtaining material and starting research.

If your research material comes from a country that has not ratified the Nagoya Protocol, there is no due diligence obligation under the Nagoya Protocol in Germany because the material is outside the scope of the EU Regulation.

At TU Braunschweig, the scientists themselves are responsible for complying with the regulations of the Nagoya Protocol. Information on the procedure is provided on this page. It is also planned to set up a contact point in the near future to provide assistance in cases of doubt.

The German Nagoya Protocol HuB in Braunschweig provides comprehensive advice on the regulations for users of genetic resources. The GNP HuB project is managed by the Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH.

The Federal Agency for Nature Conservation also offers advice and various events on the Nagoya Protocol.

The FAQ page of the German Nagoya Protocol HuB answers questions about ABS and the implementation of the Nagoya Protocol in the European Union. This information is not intended as legal advice and the DSMZ accepts no liability for the results of any action taken on the basis of the information provided.

Here you can find useful links on this topic:

• An infographic from the German Nagoya Protocol HuB that shows the decision path when using non-human biological material from outside Germany for your research.
• Nagoya Protocol Website of the Federal Agency for Nature Conservation (BfN), here you will find further information as well as contact information for the competent national authority for the Nagoya Protocol under “Responsibility”.
• Information on the biodiversity conventions of various countries and their regulations and authorities for access to genetic resources and equitable benefit-sharing can be found at Access and Benefit-Sharing Clearing-House (ABSCH). The information given here is not always up to date, so it is recommended to contact the relevant national authority.
• The German Research Foundation (DFG) has created a FAQ page on the Nagoya Protocol and the Convention on Biological Diversity, which also provides useful information on the topic.
• Whether you have compliance obligations in Germany is determined by EU law, i.e. Regulation (EU) No. 511/2014.

ABS = Access and Benefit Sharing

ABSCH = Access and Benefit Sharing Clearing-House

BfN = Federal Agency for Nature Conservation

CBD = Convention on Biological Diversity

CNA/FP = Competent National Authority/Focal Point / the competent national authority on site

MAT = Mutually Agreed Terms

MTA = Material Transfer Agreement

NP = Nagoya Protokoll

PIC = Prior Informed Consent