Scientists within the EU are obliged to exercise due diligence to determine whether the use of biological resources (so-called genetic resources) is legal within the framework of their research project. For all research supported by extramural (public) funding, the PI must make a formal due diligence declaration How do you do that? And what had to be taken into account?
This overview should help you with the necessary steps:
Due diligence declaration pursuant to Art. 7 para. 1 Regulation (EU) No. 511/2014
1) Before starting a research project
- Check at the Access and Benefit-Sharing Clearing-House (ABS-CH) whether the country of origin (where samples were collected) is a Party to the Nagoya Protocol and whether they have passed access legislation.
- If so, all necessary documents/permits must be obtained before the start of the project. If you have any questions, please contact the National Focal Point (NFP), under the respective country profile (e.g. Germany).
- If little or no information exists in the Clearinghouse, then it is wise to search online for country-specific information and to contact local collaborators in-country.
2) After project begin, you must make a due diligence declaration (pursuant to Art. 7 (1) of Regulation (EU) No. 511/2014) IF
- research funding is received (from public or private sources, although internal "house" budget funding is excluded) and
- genetic resources and/or traditional knowledge relating to genetic resources (GR) are being "utilized" ("utilization" is defined in the European regulations and guidance documents and includes, for example, basic research. However, the "use" does not include the maintenance and management of a collection for conservation purposes) and
- the "utilization" falls within the scope of Regulation (EU) No. 511/2014, i.e.
- if the country that provided the GR has signed the Nagoya Protocol (the USA, for example, has not signed) and has enacted applicable access regulations (Germany, for example, has not enacted access regulations) and
- access to the GR (i.e. the collection and not the use of the GR) was granted after the provider country had ratified the Nagoya Protocol.
TIP: The ABS-CH provides good support for researching whether and when a country became a Party to the Nagoya Protocol. Further information can also be obtained from the respective NFP.
3) When should the due diligence declaration be submitted?
- At the earliest, after the first funding has been received and the GRs have been accessed.
- At the latest, at the time of the final report or (if there is no report) at the end of the project.
4) Contents of the declaration:
- The required content can be found in Annex II of the Implementing Regulation (EU) 2015/1866.
- As the competent national authority for Germany, the BfN recommends electronic transmission via DECLARE.
- The user guide is available here
- The declaration must be made for each grant (funding source) awarded, i.e., the declaration for all GRs in a project can be combined on one declaration
- If several beneficiaries (co-PIs) receive a grant, they can either make a joint declaration or each beneficiary can make its own declaration.
TIP: If the GR was obtained from a registered collection, the registration code of this collection should be indicated in accordance with Annex II of the Implementing Regulation (EU) 2015/1866. The registration code of DSMZ GmbH, as so far the only registered collection at all, is: 01-DE-2018.
5) Consequences if the declaration is not made:
The sanctions for an infringement are determined by each country itself (Article 11(1) of Regulation (EU) No 511/2014). In Germany, the fine for each individual administrative offence can be up to 50,000 Euro (§ 4 Implementation Act).If you do not submit the due diligence declaration in a timely manner, two possible administrative offences will be committed: 1. not to collect and follow the documents required by Nagoya and 2. (§4) not to provide the information (§ 7).
Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union Text with EEA relevance
Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices (see for help also the Guidance Document)