Scope of the regulations

The Nagoya Protocol applies to the genetic resources of all organisms, excluding humans, and to all related traditional knowledge from all of the parties’ geographical areas, when they are used for research and development activities related to genetic and/or biochemical composition.  The Protocol is not valid in international waters or Antarctica. The Protocol also governs all plant genetic resources, except for those plants that are included in Annex 1 of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA). If the species determined in the Annex are utilised for other research and development activities than plant breeding, they are governed by the Nagoya Protocol.

The requirement of Prior Informed Consent is applied to genetic resources that fulfil the following three conditions:

  • the genetic resource was acquired on 12 October 2014 or later (during the Protocol’s period of validity)
  • the genetic resource was acquired from a country that has ratified/acceded the Nagoya Protocol
  • the genetic resource was acquired from a country that has access legislation in place

Not all parties to the Protocol intend to regulate the access to their genetic resources, or they may have different practices for providing genetic resources for basic research and commercial use. Additionally, it must be noted that the genetic resource’s country of origin may have requirements in its national legislation, which surpass the EU Decree’s scope of application. These requirements should be followed even if the EU’s ABS Decree would not be applied to the genetic resource in question.