The Nagoya Protocol and Access and Benefit-Sharing (ABS)

The National Implementation in the Country of Origin

In order to comply with the provisions of the Nagoya Protocol, the national jurisdiction of the Country of Origin of 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 Countries of Origin 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 Countries of Origin, 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 Country of Origin 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)

If the material is going to be passed on to other users, a Material Transfer Agreement (MTA) is also required.

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 Country of Origin, 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, researchers involved in externally funded projects are required to submit a Declaration of Due Diligence via the EU portal DECLARE during the research funding phase.

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.

Possible legal Consequences of Non-Compliance

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,
• institutional penalties imposed on the University of Bremen as well as
• individual penalties imposed on the researcher(s).

An administrative offence may result in a fine of up to €50,000 (see § 4, Article (3)). The BfN has the discretion to determine who bears primary responsibility for the non-compliance. However, violations of Regulation (EU) 511/2014 not only damage the scientific reputation of the researchers concerned, but also, and in particular, the reputation of the University of Bremen. Consequently, the university may consider making additional individual claims for damages against researchers on the grounds of academic misconduct.

Unless it can be proven that the necessity of compliance was pointed out, 

• working group leaders are liable for violations by their employees and 
• 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.

Also 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).