The Nagoya Protocol was adopted in 2010. It is a supplementary agreement to the UN Convention on Biological Diversity (CBD), which states that countries have sovereignty over the genetic resources found in their territory. Although the CBD was signed by almost all countries in the world, it contained no enforcement mechanisms. The Nagoya Protocol remedies this by providing a binding legal framework for determining how researchers and companies access genetic resources and associated traditional knowledge, and how the corresponding benefits are shared.
According to Nagoya, researchers are required to secure prior informed consent from the country of origin before accessing a genetic resource. Furthermore, the benefits that arise from the utilisation must be shared with that country. Users and providers have to negotiate and agree on the terms and conditions of access and use of the genetic resource.
In April 2014, the European Parliament and Council of the European Union adopted a regulation implementing the Nagoya Protocol. The regulation sets out further requirements aimed at EU researchers. The most striking ones are the due diligence and user compliance obligations of Articles 4, 7 and 9. Genetic resources and traditional knowledge have to be accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements. Users are required to seek, keep, and transfer to subsequent users, a certificate of compliance and information on the content of the agreed terms between the user and provider. In addition, information relevant to access and benefit sharing has to be kept for 20 years after the end of the period of utilisation. At a product’s final development stage, users also have to declare to the competent authorities that they have fulfilled these obligations. In the event of non-compliance, utilisation will be discontinued and all research will have to stop. If the research continues, the EU member states are obliged to have sanctions in place that are ‘effective, proportionate and dissuasive’.
Dutch and German plant breeders have instigated proceedings before the General Court of the European, challenging the EU regulation and in particular the excessive bureaucratic hurdles of the due diligence provisions.
The Nagoya Protocol and EU regulation will both enter into force on 12 October 2014. The provisions on user compliance in the EU regulation will apply one year later. Companies whose operations involve the use of genetic resources from other countries would be well advised to prepare for compliance.