The Nagoya Protocol implements the third objective of the Convention on Biological Diversity which relates to the fair and equitable sharing of benefits arising from the use of genetic resources. The purpose of the Protocol is to provide a legally binding framework which determines how researchers and companies who use genetic resources and traditional knowledge will obtain access to those resources. The protocol further details how any benefits from using the genetic resources will be shared.
New Regulation (EU) No 511/2014 has been drafted to implement the Nagoya Protocol in the EU. The Regulation entered into force on 9 June 2014 and has been reported by the European Commission to take effect from the date that the Nagoya Protocol itself enters into force. On 14 July 2014, Uruguay became the 50th country to ratify the Nagoya Protocol, and the protocol is now due to come into effect on 12 October 2014. EU Regulation No 511/2014 will hence take effect from 12 October 2014. However, some of the most onerous provisions of the Regulation, namely Articles 4, 7 and 9 will only take effect from one year after that date, i.e. from 12 October 2015.
Several groups have challenged the Regulation and have sought its annulment. A group of 17 German plant breeders have brought an action before the European Court of Justice and have indicated that whilst they agree with fair benefit sharing between the providers and users of genetic resources, the EU Regulation in its current form will not achieve this. The Breeders are concerned that the documentation requirements of the Regulation are impossibly onerous and that research into new plant varieties will be stifled. A similar action has been reported to have also been filed in the Netherlands. We will have to wait and see whether any of these actions will result in the Regulation being amended or annulled as requested by the Breeders.