MGR User Toolkit

European Union Regulation on Compliance

The EU ABS Regulation states that “users shall exercise due diligence to ascertain that genetic resources […] which they utilise have been accessed in accordance with applicable ABS legislation or regulatory requirements” . This obligation of due diligence means that the onus is on the user, when endeavoring research on GRs, to make sure that the applicable ABS legislation of the providing country is respected and that the GRs are acquired with the appropriate MAT and IRCC, if this is required by the providing country. This have an impact on research funding, for instance, as applications for EU or national research grants need to be accompanied by a declaration of due diligence as evidence that all the ABS obligations have been fulfilled and the relevant permit obtained. The EU ABS Regulation does not apply to GRs accessed from pre-existing collections (i.e., material obtained by the collections before the entry into force of the Nagoya Protocol – 12 October 2014).  

The Register of collections
A collection, in the meaning of the EU ABS Regulation , is “a set of collected samples of GRs and related information that is accumulated and stored, whether held by public and private entities”. For a collection to be registered, it must prove that the acquisition, storage and transfer of the samples are complying with relevant ABS legislation, and that samples are accompanied with all the relevant information and documents (MAT, IRCC and others). Users who obtain GRs from the Register are considered to have exercised due diligence as regards the seeking of the relevant information, without the need to seek further information than the one provided by the collection. Of course, the user has to stick to the intended use as specified in the PIC and MAT that comes with the GRs.

Best practice
The EU ABS Regulation also encourages the development of best practices. Mechanisms, tools or procedures by associations of users or other interested parties which enable users to comply with their obligations can be recognized as best practice by the EU Commission. The project PharmaSea started developing best practices for marin biodiscovery and part of this can be found in the section on Guidelines.