It is common practice that some research and development activities are carried out by service providers. Examples are DNA or protein sequence determination, DNA or protein synthesis and investigation of bioactive compounds and extraction methods. In these cases, who is responsible for fulfilling the due diligence obligations of the EU ABS Regulation?
Performing these activities could make the service providers users in the meaning of the EU ABS Regulation (Regulation (EU) 511/2014), which would mean that they have to fulfil the due diligence obligations of the EU ABS Regulation. However, under certain conditions it could be agreed between service providers and service requestors that these due diligence obligations are the responsibility of the service requestor only. If the following conditions are met and are explicitly set out in the service agreement, it is the service requestor that is considered to be the user in the meaning of the EU ABS Regulation, and it is the service requestor who has to fulfil the due diligence obligations:
- The service provider can only perform the activities as listed and specifically described in the service agreement, and is not granted the right to perform any other research and development or exploitation activities on the genetic resources provided or the results obtained by performing the services under the service agreement;
- The service provider has the obligation to return or destroy all material and all information pertaining to the research and development at the end of the service agreement. If a copy is kept for archiving purpose, the entity subcontracting the service will be informed thereof;
- The service provider is not granted any rights on the genetic resources or any proprietary rights related to the results obtained by performing the services under the service agreement;
- The service provider does not have the right to transfer material or information to any third party or another country and has an obligation to keep all information received and generated under the service agreement confidential (including no right to publish); and
- The service requestor has the obligation to comply with all obligations under the EU ABS Regulation related to the material provided to the service provider.
However, if one or more of these conditions are not met, it is possible (depending on the activities carried out) that the service provider is to be considered a user and that the service provider has to fulfil the due diligence obligations of the EU ABS Regulation.
For more information, see section 3.5.2 of the Guidance.