The Nagoya Protocol - Information for Project Planning
For the Application Process
FAQs:
What requirements need to be fulfilled and how is the ABS system to be correctly implemented?To begin, you should be familiar with the requirements of the provider country with whom your research is being carried out by consulting the ABS Clearing House website. In addition, it is important to work closely with colleagues in the provider country, in order to facilitate and ensure the authorisation process. This includes contacting the national authorities of provider countries and applying for permits. If you have any questions about Mutually Agreed Terms (MAT), please contact the International Law Department of the Research Law and Sponsoring Organisation Division. They will provide you with support and assistance in drafting the relevant documents.
PIC (authorisation of use) and MAT (contractual agreement regarding access conditions) are negotiated with the country granting access. Further information can be found under the relevant country in the ABS Clearing House.
The ABS Clearing House provides further information, under the relevant country, with respect to the amount of time that is needed for permits and contracts. ABS-Stories of the German Nagoya Protocol Hub also shares information from other researchers and their experience with the national authorities of provider countries. It is generally advised to plan more time for PIC (consent of use) and MAT (contractual agreement regarding access conditions) since these documents must be negotiated with representatives of the provider countries before access to genetic resources (GR) or related traditional knowledge (TKaGR) is granted.
Further information is available at the ABS Clearing House website. Please see: How do I search for certificates (IRCCs) issued to users in my country?
A country-specific list of contact persons (Competent National Authorities ‘CNAs’) can be found at the ABS Clearing House website.
The principles of the Biodiversity Convention, the Nagoya Protocol and the ABS system also apply to countries that are not parties to the Nagoya Protocol and should therefore be implemented, as much as possible. At the same time, research with non-party countries is not subject to review by the Federal Agency for Nature Conservation (BfN).
It is important to document that the relevance of the Nagoya Protocol was evaluated, considered and implemented as much as possible when conducting research involving genetic resources or traditional knowledge. At the very least, it must be documented (and archived) why the requirements of the Nagoya Protocol were not applied.
Further information and support services:
The German Nagoya Protocol HuB
The checklist „Build your ABS Strategy“ is designed to help researchers in Germany who are new to the field of Access and Benefit-Sharing (ABS). It highlights some of the most important issues researchers need to consider when preparing the ABS process and includes the following topics:
The ABS Clearing House is an information platform designed to help researchers find information on how to legally access genetic material (and associated traditional knowledge). Additional information includes:
- Country profiles and contracting party status
- Competent National Authority
- Access and benefit-sharing measures that have already been implemented (laws, regulations, guidelines)
- examples of Internationally recognised certificates (IRCC)
The Federal Agency for Nature Conservation (BfN) is the national authority responsible for implementing the Nagoya Protocol and EU Regulation No. 511/2014 in Germany. It provides services for researchers and is a first point of contact for all users and holders of collections in Germany.
Further information from the German Research Foundation (DFG ) on the Nagoya Protocol
- DFG: Nagoya guidelines for researchers
- DFG sample contract clauses for so-called ‘Mutually Agreed Terms’ (MAT)
During the Project
The declaration of due diligence documents compliance with obligations arising from the Nagoya Protocol. For third party research, it should be submitted once funding is received and, if applicable, again once the results are utilized.
If project results are used commercially for the first time, a further due diligence declaration (Annex III of the Implementing Regulation) must be submitted:
The due diligence declaration must be submitted to the Federal Agency for Nature Conservation (BfN ) electronically via the Internetportal DECLARE. It must also be submitted to the University of Göttingen, Department of Research and Transfer Services. If you have any further questions, please contact the Department of Research and Transfer Services.
Proof of the internationally recognised certificates PIC (consent of use) and MAT (contractual agreement regarding access conditions) must be submitted with the patent application.
After Completion of the Project
- Internationally Recognised Certificate (IRCC) or
- PIC (authorisation for use) and MAT (contractual agreement of access conditions)
- Due diligence declaration in the research funding phase in accordance with Annex II of Implementing Regulation (EU) 2015/1866 of 13 October 2015 Template
- and, if applicable, due diligence declaration in the product development phase in accordance with Annex III of Implementing Regulation (EU) 2015/1866 of 13 October 2015, Template