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 users of genetic resources exercise due diligence

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.

Check Points

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.

Contents of the declaration

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 (Finnish Environment Institute /Natural Resources Institute Finland) to the Finnish genetic resource registry 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.

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.