When you acquire genetic material from abroad, you may be subject to the due diligence and reporting requirements of the Nagoya Protocol. The Nagoya Protocol is an international agreement that entered into force on 12.10.2014 and has since been signed by more than 135 countries. It regulates access to genetic resources and the equitable sharing of benefits arising from their use in research and development (so-called "access-and-benefit-sharing"). The agreement was drawn up against the background of ensuring that developing and emerging countries, as providers of genetic resources, receive a fair share of the commercialisation processes that these resources undergo when they are used in industrialised countries.
Principal investigators of R&D projects are obliged to comply with the requirements of the Nagoya Protocol and the respective national regulations for the implementation of the Protocol. Below you will find important information on frequently asked questions to help you comply with the legal requirements of the Nagoya Protocol in your R&D projects at the Friedrich Schiller University Jena. In addition, members of the University of Jena have access to various additional services.
When does my R&D project fall under the Nagoya Protocol?
The Nagoya Protocol applies to R&D projects that fulfil all three of the following conditions at once:
- Acquisition of genetic resources from a signatory state of the Nagoya Protocol
Note: An up-to-date list of all signatory countries is provided by the ABS Clearing HouseExternal link.
- The genetic resource is of plant, animal or microbial origin that contains functional DNA, or its derivatives (e.g. enzymes, proteins, metabolites).
- R&D activities are carried out on the genetic or biochemical composition of the resource or its derivatives.
Under which circumstances is my R&D project exempt from the Nagoya Protocol?
The Nagoya Protocol does not apply in the following cases:
- The genetic resource is of human origin.
- Only digital genetic sequence information is used. For further information of the handling of digital genetic sequence information in regard to the Nagoya Protocol, please click here.External link
- The acquisition of the genetic resource took place before 12 October 2014.
- The genetic resource is covered by other international agreements (e.g. the International Treaty on Plant Genetic Resources for Food and AgricultureExternal link).
- The genetic resource stems from a country that has not signed the Nagoya Protocol.
- The genetic resource stems from areas outside national jurisdiction (e.g. from international waters).
My R&D project falls under the Nagoya Protocol. What do I have to do?
The principal investigator must complete the following three steps. In case that the R&D project is third-party-funded, a Due Dilligence Declaration must be submitted to the German Federal Agency for Nature Conservation (cf. point 4 below).
- Prior to the export of the genetic material, the principal investigator shall obtain a Prior Informed Consent (PIC) from the competent national authority of the provider State. Note: Contact details on competent authorities of the signatory states of the Nagoya Protocol are provided by the ABS Clearing HouseExternal link.
- The principal investigator forwards the Prior Informed Consent to the Legal Office of the University of Jena de. Subsequently, the University of Jena concludes Mutually Agreed Terms (MAT) with the competent national authority of the provider State. The agreement sets out the terms and conditions for access-and-benefit-sharing (ABS) regarding the use and commercialisation of the genetic resource.
- After concluding the Mutually Agreed Terms, the principal investigator must obtain an Internationally Recognized Certificate of Compliance (IRCC) from the competent national authority of the provider State. Alternatively, the principal investigator must collect the following information and documents in written form and pass it on to subsequent users of the resource:
- Date and location of access to the genetic resource,
- Description of the genetic resource,
- Source of supply of the genetic resources; names of subsequent users, if applicable,
- Presence or absence of access-and-benefit-sharing rights and obligations, including with respect to subsequent use and commercialisation,
- Prior Informed Consent (PIC),
- Mutually Agreed Terms (MAT).
4. In case that the resource is used within the context of a third-party funded R&D-project, the principal investigator must submit a Due Diligence Declaration (DDD) to the German Federal Agency for Nature Conservation (BfN). Due Diligence Declarations are to be set up according to EU Regulation No. 511/2014, Art. 4 (templates are provided in annex II and III of the accompanying implementation regulation 2015/1866External link). The EU portal DECLAREExternal link.is recommended for submitting the declaration. Finally, the principal investigator submits a copy of the DDD to the Servicecentre Research and Transfer
I encounter difficulties in obtaining the necessary documents. What now?
In exceptional cases, the abovementioned steps may be modified. It might be, for example, that the competent authority of the provider state explicitly abstains from negotiating Mutually Agreed Terms (MAT). Or a Prior Informed Consent (PIC) may never be issued because competent authority of the provider state does not respond despite repeated attempts to contact it. In such cases, the principal investigator is obliged to document in written form why they could not fulfil their obligations.
I use a genetic resource that falls under the Nagoya Protocol. The R&D project in which it is used is financed exclusively from budgetary funds. Do I then have to submit a Due Diligence Declaration?
No, in this case no Due Diligence Declaration has to be submitted to the Federal Agency for Nature Conservation. However, the principal investigator is still obliged to comply with all the requirements of the Nagoya Protocol regarding access-and-benefit-sharing
Who inspects and what are the penalties for violating the obligations of the Nagoya Protocol?
The German Federal Agency for Nature Conservation (BfN) conducts routine inspections of research institutions. Violations of the regulations of the Nagoya Protocol constitute an infringement, which can be punished with sanctions such as fines, confiscations and publication bans. Fines imposed on the principal investigator can amount to up to 50,000 EUR. In addition, there is the threat of criminal prosecution of the principal investigator in the country of origin of the resource.
Does the Nagoya Protocol also cover traditional knowledge about genetic resources?
According to Article 3 of the Nagoya Protocol, the rules on access-and-benefit-sharing are also to be applied to traditional knowledge related to genetic resources. At present, though, there is no internationally binding definition of the term "traditional knowledge". However, EU Guidance Document No. 511/2014, which applies in Germany, defines it as “knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources.”
I have made an invention using a genetic resource that falls under the Nagoya Protocol. What do I have to consider when patenting?
Along with the patent application, the Prior Informed Consent (PIC), the Mutually Agreed Terms (MAT) and the Internationally Recognized Certificate of Compliance (IRCC) have to be filed. If applicable, agreements mentioned in the MAT have to be observed. For further advice, please contact the Patent Information Centre of the Service Centre Research and Transfer.
internal counselling services at the Friedrich Schiller University Jena
Advice on subject-related questions
For genetic resources of microbial origin: PD Dr. Kerstin Voigt (JRMC) de
For genetic resources of plant origin: Dr. Jörn Hentschel de
For genetic resources of plant origin: Dr. Gunnar Brehm de
Advice on third-party-funding applications
Division for Research Funding, Service Centre Research and Transfer
Advice on legal issues
Legal Office: Dr. Anja Schlage de
Advice on property rights and patents
Property Rights Service / Patent Information Centre: Dr. Christian Liutik
Further information and advice
Guidelines for Researchers provided by the DFGExternal link
Counseling, information and networking opportunities
German Nagoya Protocol HuB (GNP-HuB)External link
Note: Neither GNP-HuB nor BfN offer legal advice! For juridical counseling, please contact the Legal Office of the University of Jena.
Contact details and further information on signatory states of the Nagoya Protocol
Full text of the Nagoya Protocol