How to follow the regulations

The EU’s ABS Decree (522/2014) covers the measures needed to follow the regulations in the Nagoya Protocol. This Decree implements the international rules (included in the Nagoya Protocol) which concern the duty of users of genetic resources to follow the regulations, within the EU. However, the EU member states themselves make the decisions concerning the access to their own genetic resources. The European Commission, member states and user organisations have together compiled scope of application and sector-specific instructions for users of genetic resources, in order to make it easier to interpret the Decree’s requirements.

The EU Decree requires that the users of genetic resources exercise due diligence in their operations. This means that the genetic resources used must have been acquired legally in accordance with the provider country’s legislation (Prior Informed Consent has been acquired and Mutually Agreed Terms have been negotiated), and the related documents will be kept for at least 20 years after the use of the resources has ended.  If the user carries out reasonable measures in applying for, storing, transporting and analysing the data, the user fulfils the obligation to exercise due diligence defined in the ABS Decree.

The EU Decree also determines two Check Points, which are certain phases during which the users of genetic resources must submit to the authorities a declaration that due diligence is being exercised. These stages are during the research funding phase and the product’s final development. Exercising due diligence can be proven by referring to the internationally recognised certificate of compliance (IRCC) granted to the user in question, or, if this kind of certificate does not exist, by submitting the following information:

  • the date and location at which the genetic resources (or the related traditional knowledge) were received
  • a description of the genetic resources (or the related traditional knowledge)
  • the source from which the genetic resources (or the related traditional knowledge) were directly acquired
  • the rights and obligations related to the access and sharing of benefits, or the lack of such rights and obligations (including rights and obligations related to later applications and later commercialisation)
  • the required permits related to access
  • the Mutually Agreed Terms, when necessary.

More detailed contents of the declaration have been defined in the annexes to the EU ABS Regulation (Regulation No 2015/1866). The declaration is submitted in electronic format through EU’s DECLARE site.

In addition to this, Finland’s national Act requires that the user of genetic resources or related traditional knowledge, to which regulations or orders for contract parties of the Nagoya Protocol are applicable with regard to the access and sharing of benefits, must notify a competent authority (SYKE/Luke) within a month after the import. This notification must include the information defined in Article 4, paragraph 3 of the EU’s Genetic Resource Decree.