Nagoya Protocol Compliance

The Nagoya Protocol is an international treaty that regulates the transfer of genetic resources (glossary) across borders. The foundation of this is the understanding that a state exercises sovereign rights over genetic resources within its borders, including its territorial waters. Those rights have to be observed when performing research projects. This holds true for commercial and non-commercial research, applied and fundamental research. Germany, as all EU member states, is a ratifying party to the Nagoya protocol and by this, commits itself and all researchers within its territories, to comply with its rules. In practice, this means that genetic resources cannot be transferred from another state without prior consent of the providing country. For the benefit that results from the utilisation of those resources, the providing country is entitled to a compensation. This compensation (termed “benefit-sharing”) has to be negotiated before the research project can start. Before access and initial research on a resource the negotiations with the providing country needs to be completed. This may seem impractical, but is the factual legal situation, that you have to comply with. Those negotiations can indeed take several months. We advise to take this into account when planning out your research endeavours.

The UFR wants to supports their scientists to understand and comply with these rules. Feel free to reach out to the Nagoya protocol unit for any question related to the world of the Nagoya protocol and access-benefit-sharing (nagoya@zv.uni-freiburg.de).

The information on this page will help you to judge whether the Nagoya protocol is relevant to your research. At the bottom you will find a small glossary, which may help you to navigate the language of the Nagoya Protocol.

The key topic of the Nagoya protocol is the utilisation of genetic resources and the associated traditional knowledge. The definitions of these terms are deviating from the common usage in lab slang; therefore, please find here short definitions. For more details check the links at the bottom or reach out to us.

Genetic resource (GR):

A genetic resource (GR) is every material of plant, animal, microbial, or other origin that contains functional units of inheritance (genes). Therefore, it is not relevant if the value of a resource is factual and potential. This quite open definition includes nearly all organisms that could possibly be collected from a country. Bodily fluids, e.g., urine, are subject to the protocol as it contains cellular material, harbouring DNA. The Nagoya protocol does not discriminate between domesticated and wild samples. This could be specified in national law though. This means, that a sample from a local zoo might also be subject to the Nagoya protocol related legislation. Human samples (e.g., tissue, blood) are not subject to the Nagoya protocol.

Associated traditional knowledge (aTK):

Knowledge of an indigenous or local community, that is relevant to the utilisation of the genetic resource. The knowledge per se is not subject to the Nagoya protocol, exclusively if it is used in the context of a genetic resource. Many countries have passed legislation regulating the usage of this knowledge.

Utilisation means the carrying out of research projects on the genetic or biochemical composition of genetic resource, including the application of biotechnology.

That means as soon as reasearch deals with the contents of genetic resource, it constitutes utilisation in the sense of the Nagoya protocol. This, in turn, means, that pure taxonomic identification does not constitute utilisation.

If researchers violate the regulations of the Nagoya protocol, they can get fined (up to 50,000,- €), have associated publications retracted, get access restrictions to the providing country, and suffer reputational damage. The competent national authority responsible for the control of those regulations is the Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN). Few years ago, the BFN started controlling the compliance at institutions.

All scientists working at the UFR have the responsibility to follow the regulations of the Nagoya protocol. That means, it is within the due diligence of each researcher to investigate the legal framework of their projects.

There are internal and external university offices that can support you. Your first point of contact is the Nagoya Protocol Office, which you can reach at nagoya@zv.uni-freiburg.de. We will be happy to advise you on all questions concerning the Nagoya Protocol. We will help you to evaluate your project, plan the next steps and advise how to contact the providing country. Furthermore, the University has appointed a Nagoya Protocol Representative, Prof. Alexandra-Maria Klein. If your project involves the transfer of intellectual property and/or technology transfer, we will be happy to put you in touch with the Central Office for Technology Transfer (Zentralstelle für Technologietransfer, ZfT) in order to clarify any questions that may arise.

In general, your point of contact for specific regulations in a country is the National Focal Point (NFP), which can provide you with clear information on the applicable laws and necessary documents for your specific project. It can be helpful to speak to collaboration partners in the providing country beforehand, as they often know the framework conditions well and can help you avoid bureaucratic hurdles. The authority responsible for Germany is the Federal Agency for Nature Conservation (BfN), which can also provide advice on legal issues.

Check whether the use of resources in your research project falls under the regulations of the Nagoya Protocol, and thus whether Acess-and-Benefit Sharing (ABS) would have to be negotiated. The Nagoya Protocol Secretariat provides a short questionnaire that can help you with this. If neither genetic resources nor associated traditional knowledge obtained from abroad are utilised, no further obligations arise with regard to the Nagoya Protocol.

If genetic resources and/or associated traditional knowledge obtained from abroad are utilised, the legal framework to be observed must be examined. Firstly, the scope of the EU regulations on benefit-sharing must be checked. If the project does not fall under these regulations, researchers should check whether there is further legislation on the utilisation of genetic resources and associated traditional knowledge in the providing country. If this is the case, the researchers are obliged to comply with these, regardless of whether the providing country has ratified the Nagoya Protocol and would therefore fall under the EU regulations or not. The database of the Access and Benefit-Sharing Clearing-House (ABS-CH) can help researchers to find these regulations. It is within their duty of care to carry out this check carefully. If it turns out that no benefit-sharing regulations apply to the project, researchers document the justification and keep it for 20 years. Upon request, this documentation can also be submitted to the Nagoya Protocol Office for legally secure storage in a digital documentation system

If researchers come to the conclusion that their project is covered by the Nagoya Protocol or by analogous national legislation, they first contact the National Focal Point (NFP) of the providing country where these enquiries are to be processed. Researchers can usually find the contact details of the NRP in the Access and Benefit-Sharing Clearing-House (ABS-CH) database. If the researchers already have collaboration partners in the providing country, for example, it may be advisable to discuss the case with them, as they can help with language barriers and bureaucratic hurdles. The Nagoya Protocol office can provide researchers with an E-mail template for initial contact. Depending on the NFP’s response, researchers will have to deal with different scenarios.

1. No response: If there is still no response from the NFP after three independent attempts at one-month intervals, researchers must first contact the Nagoya Protocol Secretariat to plan the next steps together. Researchers must not start their project without the necessary authorisations from the providing country (EU standard 511/2014 Art 4.5).
2. The NFP of the providing country informs the researcher that the project is not in the scope national legislation. The researchers have no further obligations except to document this communication and send a copy to the Nagoya protocol office.
3. The NFP of a donor country can issue researchers with a waiver for their project, i.e. waive the application of legislation. Researchers must document this declaration and keep it for 20 years after the end of the project. A copy of the communication containing this waiver of further conditions must be sent to the Nagoya protocol office for legally secure storage.
4. The NFP informs the researchers about legislation and the requirements that apply to their project. Negotiations now begin on an access-benefit-sharing agreement (Mutually Agreed Terms, MAT) and the access permit (Prior Informed Consent, PIC). The Nagoya protocol officer and the Nagoya protocol representative can provide support here, but in principle the negotiations remain the responsibility of the researchers. In necessary cases, the university’s legal department and/or the Central Office for Technology Transfer (Zentralstelle für Technologietransfer, ZfT) can also be consulted. This must be clarified by the Nagoya protocol office on a case-by-case basis. The obligation to sign lies with the researchers. If providing countries require the signature of the institution management, the signature obligation is transferred to the university management in this justified case. However, this requires a mandatory legal review by the UFR legal department. If the benefits to be shared in the Mutually Agreed Terms (MAT) relate to technology transfer, the Central Office for Technology Transfer must be involved before signing.

Once researchers have received all authorisations from the providing country, they can start procuring and using the resource. Copies of the authorisations must be sent to the Nagoya protocol office within 3 months of signing for legally secure filing. If requested by the researcher, the Nagoya protocol office can register the project with ABS-CH and apply for an internationally recognised certificate of compliance (International Certificate of Compliance, IRCC). This facilitates future documentation and dissemination of material. Furthermore, project leaders are obliged to comply with the following regulations:

1. Researchers are obliged to keep all relevant documents for 20 years after the end of the project, even if the project or utilisation of the resource ends earlier.
2. If a project that utilises genetic resources or associated traditional knowledge is third-party funded and falls under EU regulations, a due diligence declaration (DDD) must be submitted to the EU’s DECLARE database in accordance with EU standard 511/2014 Art. 7.1. Researchers prepare these together with the Nagoya protocol office. The Nagoya protocol office submits this to DECLARE.
3. Researchers are obliged to comply with all conditions of their authorisations. If researchers share genetic resources or associated traditional knowledge with other researchers, all parties involved must ensure that the relevant authorisations allow this. When transferring genetic resources and associated traditional knowledge, copies of the relevant documents must be given to the recipient.

Advantages in benefit-sharing negotiations can be monetary and non-monetary. Funds for benefit sharing payments can be included in third-party funding applications.

(Non-conclusive) list of possible benefits:

• Monetary
  • access fees per sample
  • advance payments
  • milestone payments (e.g. after sampling)
  • shares in case of commercialisation*
  • shared intellectual property*

• Non-monetary
  • sharing of research results*
  • visible external presentation, e.g. via co-authorships
  • agreements on further collaborations
  • training opportunities for scientists from the providing country

*If the shared processes relate to technology transfer in the narrower sense, the Central Office for Technology Transfer (ZfT) must be involved before the contract is concluded.

All benefit-sharing processes can be published centrally on a database (the ABS-CH). It is also possible to publish PIC and MAT (on a voluntary basis). It is also possible to apply for an IRCC there. This is a handy, small, internationally recognised certificate that confirms the validity of PIC and MAT. You do not have to apply for it, but it is a very useful document in the case of examinations and transfer of material.