Advances and uncertainties in compliance measures for users from the Nagoya Protocol in the European Union

The Nagoya Protocol developed the legal regime for the access to genetic resources and the fair and equitable sharing of benefits arising from their utilization that were already enshrined in the Convention on Biological Diversity, and introduced binding rules on compliance. With its Regulation 511/2014 adopted in 2014, the European Union (EU) – the second most important geographical area in the global biotechnology market – has developed and sought to harmonize the compliance and monitoring measures for users from the Nagoya Protocol in the EU territory. This article presents and assesses the progress made in this recent EU legal field, including the challenges in the form of several uncertainties that still lie ahead