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Cow and DNA strand.

The scope of the Nagoya Protocol and of Regulation (EU) No 511/2014 includes research and development on genetic resources (or traditional knowledge associated with them) regardless of whether it is undertaken for commercial or non-commercial purposes. It is to be noted that the scope of the EU Regulation includes both (pure) research (basic research) and (pure) development, and it is not necessary for both research and development activities to be present. On the other hand, it does not include purely hands-off research that does not involve working on the genetic and/or biochemical composition of genetic resources.

Guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014 (Notice No 2016/C 313/01)

Due diligence

Basic research on genetic resources (or traditional knowledge associated with them) is therefore subject to the due diligence obligation under Article 4(1) of the EU Regulation.

Points to watch in complying with the due diligence obligation under Article 4(1) of the EU Regulation

  • Documentation: Users must seek, keep and transfer to subsequent users the information on the legality of access and on benefit sharing listed in Article 4(3)(a) and (b) of the Regulation. The retention period is 20 years after the end of the period of utilisation (Article 4(6)). 
  • Risk assessment: When the information in their possession is insufficient or uncertainties about the legality of access and utilisation persist, users must, in order to satisfy the due diligence obligation, subsequently obtain an access permit or its equivalent and establish mutually agreed terms on benefit sharing, or discontinue utilisation (Article 4(5)).
  • Risk reduction: Finally, users can reduce the risk of non-compliance with the due diligence obligation by obtaining their genetic resources from a registered collection (Article 4(7)) and/or by implementing a best practice (Article 9(1)).

Declarations

Since 10 May 2018 recipients of research funding in connection with the utilisation of genetic resources (or of traditional knowledge associated with genetic resources) are obliged to submit, at the research funding stage, a due diligence declaration in accordance with Article 7(1) of the EU Regulation (this is in addition to the general obligation to exercise due diligence under Article 4 of the EU Regulation). Due diligence declarations can be submitted via the EU-wide web-based tool DECLARE.

Research funding is defined as any financial contribution by means of a grant to carry out research, whether from commercial or non-commercial sources (Article 5(5) of Implementing Regulation (EU) 2015/1866). Internally funded research is not considered to be research funding within the meaning of Article 7(1) of the EU Regulation.

User guide/Questions and answers – DECLARE NAGOYA IT system
Access to DECLARE

Support from Deutsche Forschungsgemeinschaft

Deutsche Forschungsgemeinschaft (DFG) (the German Research Foundation) provides financial support for scientific research projects and promotes collaboration among researchers. The DFG Senate Commission on Biodiversity Research has set up a working group on Access and Benefit Sharing (ABS) which advises the Commission on requirements for research projects under the 
Convention on Biological Diversity (CBD). The ABS Working Group supports the CBD process with the aim of promoting the specific needs of basic research on biodiversity. It drafts directives and model contractual agreements to ensure conformity of DFG-funded projects with the stipulations of the CBD, the Nagoya Protocol, the national laws of provider countries, and European and German ABS legislation. 

The interdisciplinary working group is currently revising its Guidelines for Funding Proposals Concerning Research Projects within the Scope of the CBD.

Contact:

Deutsche Forschungsgemeinschaft (DFG)
German Research Foundation
Dr. Meike Teschke
Programme Officer Life Sciences 1: Molecular and Organismic Biology
Kennedyallee 40
53175 Bonn, Germany 
Tel:        +49 0228 885-2336
Fax:       +49 0228 885-2777
E-Mail:   meike.teschke@dfg.de 
 
 

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