The Nagoya Protocol

The National Implementation in the Provider Country

In order to comply with the provisions of the Nagoya Protocol, the national jurisdiction of the country providing the genetic resource must be followed. Access and Benefit-Sharing (ABS) to genetic resources are governed by this national scope of the Nagoya Protocol.

The so-called Provider Countries are entitled to make access to their genetic resources subject to certain conditions. They can demand "fair and equitable sharing of the benefits arising out of the utilization of genetic resources". In some Provider Countries, reseachers have been imprisoned for violating national ABS laws.

Users of material that falls under national jurisdiction according to the Nagoya Protocol are required to obtain from the Provider Country of the genetic resource the following documents, to retain them and to transfer them to subsequent users:

1. "Prior Informed Consent" (PIC)
2. "Mutually Agreed Terms" (MAT) (where appropriate)

The EU ABS Regulation for Implementation in the EU

The Regulation (EU) No. 511/2014 governs the implementation of the Nagoya Protocol obligations in the EU. All research projects that have obtained access to genetic resources (and/or traditional knowledge) and fall within the scope of the Nagoya Protocol, according to the jurisdiction of the Provider Country, are obliged to comply with the EU ABS Regulation.

Researchers are obligated to exercise due diligence and have a duty of explanation and cooperation in the event of an inspection by the national authority for the implementation of the Nagoya Protocol, the Federal Agency for Nature Conservation. In addition, the recipients of research funds are required to submit a Declaration of Due Diligence during the funding phase of the research.

If the research/utilization (as a non-commercial laboratory analysis) is being conducted in Germany, the EU ABS Regulation also applies to research projects carried out jointly with partners from third countries. Whenever researchers are involved as co-authors, they are considered users in the sense of the EU ABS Regulation.

In Germany, violations of Regulation (EU) No. 511/2014 constitute regulatory offences. For further informations, see below.

Possible legal Consequences of Non-Compliance

This list is not exhaustive.

A violation of Regulation (EU) 511/2014 constitutes an administrative offence in Germany.

In connection with an administrative offence, it is at the discretion of the Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN) to impose a penalty.

This may include

• destruction of samples
• deleting all associated of data
• ordering the publisher to withdraw the publication concerned
• individual penalties:
  • each researcher may be personally fined ≥ €50,000 by the BfN per violation. It should not be assumed that this fine is covered by labour law or the employment relationship with the University of Bremen. In case of doubt, it constitutes an individual fine to be paid personally.
  • Unless it can be proven that the necessity of compliance was pointed out, working group leaders are liable for violations by their employees. Supervisors are liable for violations by bachelor's students, master's students and doctoral candidates. If the supervisor is a doctoral candidate, the working group leader/research group leader is liable.
  • Postdocs are already liable in individual cases.
  • please see §3(2) of 'Ordnung der Universität Bremen zur Sicherung guter wissenschaftlicher Praxis [...]' (currently only in german)
• Institutional penalties imposed by the BfN on the University as a whole may be imposed separately, but in this case the individual researchers will not be prosecuted by the BfN.

Violations of Regulation (EU) 511/2014 damage the scientific reputation of the researchers concerned, and the reputation of the University of Bremen as a whole. Therefore, the University may consider asserting (additional) claims for damages on an individual basis, which would be added to the fines imposed by the BfN.