Implementation of Regulation (EU) No 511/2014

DIB fully supports the objectives of the Convention on Biological Diversity (CBD) and of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Benefit Sharing of Benefits Arising from their Utilization. A key driver in the process of implementing the Nagoya Protocol must be to ensure legal certainty for potential users and providers of genetic resources in the EU. Otherwise both the use of genetic resources and the development of new products therefrom will be severely hampered.

DIB fully supports the objectives of the Convention on Biological Diversity (CBD) and of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Benefit Sharing of Benefits Arising from their Utilization.

A key driver in the process of implementing the Nagoya Protocol must be to ensure legal certainty for potential users and providers of genetic resources in the EU. Workable regulations should apply which also small and medium-sized enterprises can fulfill without extra administrative workload in their usual day-to-day activities. It is important to keep this administrative workload as low as possible. Otherwise both the use of genetic resources and the development of new products therefrom will be severely hampered. This would run counter to the objectives of the CBD as well as the Nagoya Protocol.

We therefore outline a number of points which we consider should be addressed and/or clarified in the draft of the “Commission Implementing Regulation (EU) No …/… laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices”as well as in its annexes so as to ensure an effective and balanced implementation of the EU Regulation.

It can generally be taken for granted that access to genetic resources in situ and ex situ without the authorization of the country of origin is more of a theoretical exception. This would constitute a violation of the CBD (misappropriation, misuse) and is equally to be condemned as access without obtaining a PIC. The industry draws attention to the fact that binding regulations should be exemplified by normal cases, and not by exceptions (e.g. misappropriation), since anything else would be a serious threat to any efficient and practicable procedure.

Article 15 (3) requires CBD Parties to facilitate access for environmentally sound purposes and not impose restrictions that are counter to the CBD. The current overall impression industry has from this draft regulation is that the EU Commission’s focus is strictly on extensive control instead of fostering the sustainable use of genetic resources and thus triggering investments in its protection and conservation. We urge the EU Commission to continue to actively involve stakeholders throughout the process of drafting the regulation