Who is a user within the meaning of the Nagoya Protocol?

The Nagoya Protocol sets the legal framework for access to genetic resources, as well as the sharing of benefits arising from their utilisation. The Nagoya Protocol is characterized by the concept of "user" (Article 4 of the EU ABS Regulation). This defines control obligations, monitoring measures by the competent authority, and sanctions. Who is a user within the meaning of the Nagoya Protocol? Responsibility can therefore fall on those responsible for a genetic engineering facility (operator, project manager, and biosafety officer) or even on the employees themselves? According to Article 3(4) of the EU ABS Regulation, any natural or legal person who uses genetic resources or traditional knowledge related to genetic resources is referred to as a "user." Utilisation of genetic resources occurs, for example, when research and development activities on the genetic and/or biochemical composition of genetic resources are carried out, including through the application of biotechnology. Examples include quality assurance, authentication, verification, and the description of genetic resources in phenotype-based research, and the use of genetic resources for testing and reference purposes. Accordingly, the concept of use is significantly more actively oriented than that of the operator of a genetic engineering facility. Even if a legal entity can be a user within the meaning of Article 3 (4) of the EU ABS Regulation, the natural person who uses the genetic resources or traditional knowledge remains a user within the meaning of the EU ABS Regulation. Accordingly, in recent times, the Federal Agency for Nature Conservation (BfN) has directly contacted a researcher whom it identified as a user of genetic resources subject to the Nagoya Protocol through an online publication. This researcher will also be hard-pressed to exonerate themselves by arguing that the research institution should be held accountable, because the research institution itself may not profit from the research. This primarily flows back to the researcher via the publication and the associated scientific value for the researcher, but not directly to the university.

Conclusion: If one actually actively links to the use, it is quite questionable whether the university ( chancellor as operator) as one who does not use the software itself. The classic description of the work of a project manager (PL) who is responsible for the planning, management, or supervision of genetic engineering work is not primarily considered a user. Only if the PL directly carries out the work themselves can they be directly considered a user within the meaning of the EU ABS Regulation. The Biosafety Officer is also (BBS) , whose responsibilities include reviewing the work of the PL and advising the operator, is likely to lack proximity to active use. This is because his/her area of ​​responsibility does not primarily make him/her the direct user of a genetic resource. Accordingly, ultimately those who researchers in the laboratory, those who are actually actively pursuing research on a particular genetic resource, or their institutes. Neither can be denied the benefit of using genetic resources.