Humboldt-Universität zu Berlin

Nagoya Protocol

In research, for example in the fields of biology, medicine, virology, nutrition, where plant or animal materials are used, the requirements of the Nagoya Protocol must be complied with where appropriate. The protocol is relevant for all research projects in which certain genetic materials are used or processed, or which investigate traditional knowledge about the plants and animals from which the material was obtained. The aim is to ensure that the countries from which the research resources are obtained also participate appropriately in any potential successes.

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Research with and on genetic materials of animal or plant origin

The Nagoya Protocol is an instrument of international law which seeks to ensure "the fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components." Art. 1, Nagoya Protocol

 

Basics

In which cases may the Nagoya Protocol need to be adhered to? 🖉

Research fields, examples:

  • Nutrition
  • agriculture
  • Geoscientific research
  • Medicine (human pathogens)
  • Cosmetics
  • Bio-based energy sources
  • Molecular biology
  • Genetic analyses (with non-human material)
  • paleonthology
  • microbiology
  • Synthetic biology

Use the checklist (de/en) (under Supporting material) to check whether your research project is relevant to Nagoya.

Which genetic material and ressources are covered by the Nagoya Protocoll? 🖉

The Protocol is relevant for all research projects in which certain genetic materials are used or processed, or which investigate traditional knowledge about those plants and animals from which the material was obtained.

These are the definitions in the EU Regulation (511/2014 in Article 3, paragraphs 1, 2 and 7):

  • Genetic materials, i.e. any material of plant, animal, microbial or other origin that contains functional units,
  • genetic resources, i.e. genetic material with actual or potential value, but also
  • traditional knowledge relating to genetic resources belonging to an indigenous or local community, or indigenous or local community relevant to the use of the genetic resources.
Legal bases relevant to researchers 🖉

When conducting research with and on genetic materials and resources, both the legal requirements on the European side and those of the provider states must be observed. Particularly relevant on the European side:

The EU Regulation, which is directly binding for all researchers: EU Regulation (511/2014): Link

The Implementing Regulation laying down detailed rules for the implementation of Regulation (511/2014) of the European Parliament and of the Council as regards the register of collections, compliance monitoring by users and best practices informs users how and what to document and how due diligence obligations should be ensured (the Annex to the Regulation also contains templates). EU Implementing Regulation (2015/1866). Link

The (German) Act Implementing the Obligation under the Nagoya Protocol and Implementing Regulation (EU) No. 511/2014 defines the tasks and powers, orders and remedial measures as well as provisions on fines. The competent authority for this in Germany is the Federal Agency for Nature Conservation. Link

List of countries that have signed the Nagoya Protocol. Link

Researchers must continue to comply with the laws and regulations of the providing countries. This applies regardless of whether the provider countries have signed the Nagoya Protocol or not. To find out more about this, researchers can also access the ABS Clearing House via the website of the Federal Agency for Nature Conservation. Here you will also find extensive further information on the utilisation of genetic resources.

Applicability: When do the provisions of EU Regulation (511/2014) apply? 🖉

If the requirements of EU Regulation (511/2014) are not met, its regulations (due diligence obligation with regard to obtaining, storing and forwarding documents, Art. 4, and obligation to submit a due diligence declaration, Art. 7) do not apply.

The requirements for the applicability of the regulation are:

  • Access in a state party to the Nagoya Protocol after 12.10.2014
  • Access at a time when ABS regulations apply there for the specific genetic resource that is to be utilized
  • Utilisation of this genetic resource in the EU

If only one condition is not met, the EU Regulation does not apply. [Reply from the BfN, 18.03.2024]

The signing of the Protocol alone does not lead to an obligation to implement the Protocol, but only its ratification through a further legal act (see on the status of ratification procedures: Link ) (BfN response, 05.04.2024).

EU Regulation No. 511/2014 therefore does not apply if access to genetic resources takes place in a country that has national ABS (Access Q Benefit Sharing) regulations but is not a party to the Nagoya Protocol. Nevertheless, users of genetic resources must comply with these national ABS regulations when accessing genetic resources. However, there is no official review of this within the EU due to the lack of applicability of the aforementioned EU Regulation (BfN response dated 05.04.2024).

⇒ see the checklist under "Support and assistance from HU".


Support and assistance

External support

Where can I find information on the Nagoya Protocol 🖉

There are numerous excellent external sources of information and support on the Nagoya Protocol:

  • The German Nagoya Protocol HuB is a project funded by the German government (Federal Agency for Nature Conservation (Bfn) and Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU)) that aims to support researchers to better understand all legal obligations of the Nagoya Protocol. It is carried out by the following institutions: Leibniz Institute DSMZ-German Collection of Microorganisms and Cell Cultures GmbH (DSMZ), The Consortium "German Natural Science Research Collections" (DNFS), Leibniz Research Network Biodiversity (LFN BioDiv), Association of Biology, Biosciences and Biomedicine e.V. (VBIO)
  • DFG explanations for researchers: DFG (2021): Explanatory notes on research and/or development projects involving access to genetic resources and/or traditional knowledge associated with genetic resources.
  • Comprehensive information can also be found on the website of the Federal Agency for Nature Conservation (BfN)

 

Support from the Humboldt-Universität zu Berlin

Checkliste Nagoya Protocol 🖉

The checklist will help you to decide whether your research is subject to the EU Regulation (511/2014). You fall under the scope of application if you answer all of the following questions in the affirmative. Even if your research does not fall under the EU Regulation, you must comply with the national provisions of the provider country that apply independently of the Nagoya regime!

To the checklist: Link

Parties to the Nagoya-Protocol: Link

check-list countries [Intranet]: Link

If you wish to apply for a research project and you have determined from the checklist that it is relevant to Nagoya, the SZF recommends that you contact the SZF immediately. Before projects can be applied for, the requirements resulting from the Nagoya Protocol must be researched and documented. Funding bodies expect applicants to show that they are informed, e.g. by mentioning the national focal point or how benefit sharing is to be realized. The resources concerned can only be utilised once all the requirements of the Nagoya Protocol have been met. As the processes for obtaining Prior Informed Consent (PIC) from the donor countries and, if necessary, drawing up various contracts take a long time, it is advisable to obtain information as early as possible.

You will receive a checklist form from the SZF at the latest when the project is set up, with which you confirm with your signature that you have checked your research project for possible Nagoya relevance.

These documents should be prepared 🖉

Depending on the requirements of the providing country, different documents may have to be prepared, which must also be presented in the event of possible controls (compilation according to DFG (German Research Foundation). (2021). Explanatory notes on dealing with the legal requirements of the Nagoya Protocol and Regulation (EU) No. 511/2014 in universities and other research institutions. p. 30 f). Link

  • Prior Informed Consent (PIC): Declaration of consent from the providing country for the implementation of the research project
  • Mutually Agreed Terms (MAT): This contract regulates the utilisation of the genetic resource as well as, for example, the place of collection, scope, objective, time frame of utilisation and, if applicable, the responsible persons
  • Material Transfer Agreement (MTA): A contract that regulates the export of the material and, if applicable, regulations on what to do with the material after the project is completed.
  • Research Permit: Combination of PIC and MAT in one document. An export licence can also take the place of an MTA.
  • Internationally Recognised Certificate of Compliance (IRCC): Providing countries can submit their PIC and MAT to the ABS Clearing House. They are then published there as an IRCC.
  • Due Diligence Declaration: For research projects with project funding, a due diligence declaration must be submitted at the earliest after the first funding has been provided and the genetic resources or traditional knowledge relating to them has been obtained and at the latest four weeks before the end of utilisation. The due diligence declaration is submitted via the Research Service Centre via the EU's DECLARE portal. HU researchers must first complete a corresponding form with the necessary information.

 

Questions & Answers

Retention obligations: Do the materials also have to be stored for 20 years? 🖉

The retention obligation arises from Art. 4 para. 3 sentence 1 Regulation (EU) No. 511/2014 (hereinafter EU ABS Regulation) and only relates to the documents. There are no retention obligations for the material under the aforementioned regulation. [Reply from the BfN, 18.03.2024]

Does a due diligence declaration have to be submitted for research that is not externally funded? 🖉

Internal budget funds of private or public institutions are not "research funds" within the meaning of Art. 7 para. 1 of EU Regulation (511/2014). In the case of self-financed research involving the utilization of genetic resources within the scope of the EU ABS Regulation, no due diligence declaration pursuant to Art. 7 para. 1 must therefore be submitted.

Even if no due diligence declaration according to Art. 7 para. 1 EU Regulation (511/2014) has to be submitted, the due diligence obligation from Art. 4 applies to all research involving the utilization of genetic resources within the scope of the EU ABS Regulation. This can be checked by the BfN as part of user inspections. [Reply from the BfN, 18.03.2024]

 

You can find more information in the intranet below https://hu.berlin/intranet-nagoya-protokoll

Please use our functional address to contact us:

nagoya.szf@hu-berlin.de