Research involving genetic resources - The Nagoya Protocol

The Nagoya Protocol was adopted in the context of the 10th meeting of the Conference of the Parties to the Convention on Biological Diversity in order to ensure the equitable sharing of benefits arising from the utilisation (including research) of genetic resources. The protocol aims to reconcile the interests of the countries of origin of such resources and the countries where such resources are utilised. The English term for this is “Access and Benefit Sharing", or ABS.

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

Anyone conducting research on non-human genetic resources or associated traditional knowledge must be familiar with the Nagoya Protocol. In this context, “genetic resources” are defined as genetic material of actual or potential value as long as it is of plant, animal, microbial or other origin containing functional units of heredity. For example, this includes animals and plants or parts of them, seeds, seedlings, fungi, bacteria and other single-celled organisms as well as cell cultures, spermatozoa, ova, chromosomes and DNA.

The protocol does not apply to human genetic resources.

In 2016, Germany committed to implement the Nagoya Protocol as well as the related EU Implementation Regulation (EU) 511/2014. This means: If you intend to conduct research on genetic resources originating from another country in Germany, you need to check whether this country has implemented individual regulations on Access and Benefit Sharing (ABS) and whether these regulations apply to your research.

If this is the case, you are obliged to complete the ABS process, as stipulated in the requirements of the country of origin, prior to commencing the project. It may be necessary to conclude a contract with the national authorities regulating access to the material or its utilisation.

Irrespective of specific ABS requirements of the country of origin, you are also required to fulfil due diligence obligations in accordance with the EU regulations if the Nagoya Protocol applies in the country of origin of the resources. For this purpose, you need to document that you have endeavoured to obtain information on ABS to the best of your knowledge, and that you have used this information as a basis for decision-making. If you are in receipt of third-party funding, you will also be required to submit due diligence declarations during the project term. In order to submit these declarations, you need to access the EU’s DECLARE portal.

Whether the provisions of the Nagoya Protocol apply to your research depends on the following factors, which must be evaluated on a case-by-case basis:

        the type of biological material used,

        its origin,

        the time of removal, as well as

        the type of conducted research.

A detailed checklist can be found on the website of the Nagoya Protocol HuB.

• Contact the relevant authorities in charge of ABS in the provider country and obtain information on requirements for accessing the resources, as well as on the process for utilising them. If there are no ABS rules, no further action is required.
• If the ABS regulations include fees for the utilisation of genetic resources, please clarify with the funding body whether these can be covered within the scope of project funding.
• Document all measures you have taken with regard to ABS regulations, so that they are transparent in case you should leave the project or if the biological material in question is passed on to other persons or facilities (retention period: 20 years!). Among others, this includes the following documents: Declaration of consent of the provider country for conducting research, agreement on utilising the genetic resource, material transfer agreement, certificate of compliance.
•  In addition, document metadata regarding the genetic resource, its storage, utilisation, securing etc.
• Prepare the due diligence declarations to be submitted via the EU’s DECLARE portal after the launch of the project and before the project is completed. These documents will be checked by the Federal Agency for Nature Conservation (BfN).

In general, researchers at Leibniz University Hannover are responsible for complying with the regulations of the Nagoya Protocol. University management provides information regarding the procedure on this website and will soon implement a point of contact offering guidance in case of doubt.

Depending on the regulations of the provider country, failure to comply with ABS regulations may result in regulatory consequences, such as a research ban in the affected country. Violations of the European and German implementation acts of the Nagoya Protocol may result in the confiscation of the biological material and further utilisation may be prohibited. Moreover, a fine of up to €50,000 may be imposed. Other non-regulatory damages resulting from sanctions in the context of violations of the Nagoya Protocol include reputational damage as well as limited cooperation or publication opportunities.

 The German Nagoya Protocol HuB in Braunschweig provides in-depth guidance on regulations.

 Moreover, the Federal Agency for Nature Conservation offers guidance and various information events focusing on the Nagoya Protocol.

Co-authors of a publication using genetic material must ensure that the material was lawfully obtained by the person who carried out the analysis. It is irrelevant whether the research was conducted in your own laboratory or elsewhere.

If it is unclear whether a country has established ABS legislation, or if contact persons are unavailable, we recommend documenting any steps taken. In case of doubt, consider alternative supply options. Users should carry out a risk assessment.

One permit covers all organisms collected during a field campaign. There is no need to obtain separate permits for individual organisms.

If the material was collected before the Nagoya Protocol (12.10.2010) and the Convention on Biological Diversity (CBD, before 1993), it is possible to state that the country of origin is unknown; however, for material collected after 12.10.2014, this is no longer permitted.

If the strain is available in Germany, please use this strain instead of the foreign one. This clarifies the origin. Alternatively, you can obtain the strain from a registered collection, which guarantees that the strains have been acquired legally.

In some cases, fees are required to obtain an ABS permit. Ideally, this should be listed transparently on the website of the relevant authority. If there are any fees, please check if your grant agreement covers this.

If Regulation (EU) No. 511/2014 does not apply to your research, you are not required to provide evidence of this.

However, we recommend documenting the time of sampling or access to the material in the provider country, as well as copies of correspondence or other records stating that your material is not covered by ABS obligations. This may be useful if the Federal Agency for Nature Conservation (the relevant authority in Germany) conducts a user check.