The "Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization [...]" entered into force on 12 October 2014. This international agreement is relevant for all researchers working with biological material and/or related traditional knowledge that originates from outside Germany (see below for definition).
The University of Bremen recognizes the importance of complying with the Nagoya Protocol. The Nagoya Compliance Officer provides support for its implementation and helps all reseachers to understand and comply with their obligations under the Nagoya-Protocol and the EU ABS Regulation.
It is important to respect both the regulations in the countries providing the genetic resource and the regulations at EU level!
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:
- "Prior Informed Consent" (PIC)
- "Mutually Agreed Terms" (MAT) (where appropriate)
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 and can result in fines of up to €50,000, confiscation of the material and suspension of the research project.