Report on the first AGCT Nagoya Workshop on July 26, 2023

On June 26, 2023, AGCT Consulting GmbH held its first workshop on the Nagoya Protocol at the request of participants in a previous refresher course. The Nagoya Protocol is an international treaty that regulates the handling of genetic resources in laboratories. The aim is to create a balance between states that use these resources and those from which they originate. During the workshop, Dr. Petra Kauch (AGCT) first explained the legal basis for the protocol under international law, the European ABS Regulation, and the German implementation law. She also pointed out that the Nagoya Protocol itself obliges states and not users. Dr. Scarlett Sett (ABS/Nagoya Protocol compliance officer at Kiel University and advisor in the BfN hub) then defined the specific user obligations under the ABS Regulation. The focus was also on the question of how an institution, e.g. For example, a university can create the organizational structures necessary to comply with the requirements of the ABS Regulation. Dr. Laura Korte (ABS Manager, Bayer AG) then demonstrated practical information gathering using examples involving genetic resources from Austria, France, Chile, Kenya, and Australia, both live and online. Participants came from universities, public research institutes, and private companies. Many of the participants hold the role of compliance officer or manager within their organizational structure, responsible for the Nagoya Protocol. The course therefore primarily provided an opportunity to exchange views on the various organizational structures that the participants have implemented or intend to implement in their companies or institutions. Three key areas of discussion emerged during the course:

1. The target group of user obligations:

Who actually constitutes a user within the meaning of the ABS Regulation? Why might the user status be different in a company than in a university? What about third-party funded research institutions?

A user, as defined by the ABS Regulation, tends to be the person who derives a benefit from the genetic resource. In a university, this is usually the individual researcher or institute, not primarily the chancellor or the university. In comparison, a private company generally derives the benefit from the use, not the company's employees. For third-party funded research institutions, this will have to be reviewed on a case-by-case basis.

2. The optimal organizational structure and the creation of problem awareness among employees:

Even though researchers tend to be users within the meaning of the ABS Regulation, it makes sense to create certain centralized structures within the organizational structure. Participants particularly emphasized central data collection and centralized documentation archiving, a central competence center for inquiries (ABS Officer), and centralized organization of training, continuing education, and awareness-building.

3. The retrospective review of the genetic resources used:

The Nagoya Protocol operates with a cut-off date, having entered into force on October 12, 2014. Therefore, material acquired/used after October 12, 2014, is relevant. In principle, the requirements of the ABS Regulation must be met before first use. This is because the countries of origin should benefit from the internationally recognized certificates of conformity (IRCC) or be able to co-determine the conditions for such use prior to use (so-called prior informed consent, PIC & mutually agreed terms, MAT).

Nevertheless, it sometimes happens that institutes/universities/companies have not met the requirements for past periods. The course participants therefore discussed how information on utilized genetic resources can be researched retrospectively and compiled centrally. As a result, using simple queries to researchers, the species used, the research objective, and the country of origin of the resource could be obtained and compiled. Once a standardized data set is available, it can be checked for compliance with the Nagoya Protocol and the ABS Regulation for each genetic resource using a developed checklist. Ultimately, the participants also realized that dealing with the ABS Regulation is not a "one-time project" but an ongoing task. Research regarding the country of origin, an internationally recognized certificate of conformity (IRCC), and the scope of permitted use must be continually reviewed, as all parameters can change during the period of use. For this reason alone, we will soon be offering the event again as a workshop (probably in the second week of December) on a semi-annual basis.

A first opportunity for employees to approach the topic is our AGCT Refresher Project Manager Course (day course) on September 6, 2023, which also provides a refresher on genetic engineering expertise. Please feel free to contact us for more information. Homepage .