Prior informed consent and import notification for genetic resources
How to follow the regulations
The Regulation (EU) No 511/2014 requires that the users of genetic resources or associated traditional knowledge (aTK) exercise due diligence in their operations. This means that genetic resources to be utilised must have been acquired legally in accordance with the providing country’s legislation, and the related documents will be kept for at least 20 years after the utilisation of the resources has ended.
Applying for Prior Informed Consent
If you import biological material from abroad for research and development purposes or use genetic resource resources for research and/or development, you should
- acquire Prior Informed Consent (PIC) and
- negotiate Mutually Agreed Terms (MAT)
if recquired by the providing country.
PIC must always be acquired when traditional knowledge (associated with genetic resources) of indigenous peoples is utilised.
Applying for Prior Informed Consent
PIC is applied for in accordance with the instructions provided by the providing country’s competent authority (CA) or the ABS contact point (NFP: National Focal Point). The contact information for the authorities is available on the international information exchange platform (Access and Benefit Sharing Clearing-House, ABSCH).
The Finnish Environment Institute acts as Finland's national ABS Focal Point.
Import notifications
The user of genetic resources or associated traditional knowledge must notify the competent authorities within a month of import. The Finnish competent national authorities are Natural Resources Institute of Finland and the Finnish Environment Institute.
- Make an import notification electronically to the genetic resource register
- Use of genetic resources (biodiversity.fi)
The Nagoya Protocol promotes access to the world's genetic resources
The Nagoya Protocol (ABS, Access and Benefit Sharing) is an international agreement whose objective is to promote access to genetic resources in the world and the fair and equitable sharing of benefits arising from their utilisation while promoting conservation of biological diversity and sustainable use of natural resources. The protocol was approved at the meeting of the parties to the Convention on Biodiversity (CBD) in 2010 and it entered into force internationally in 2014. Finland became a party to the Nagoya Protocol on September 1, 2016.
What are genetic resources?
Genetic resources are not separately defined in the Nagoya Protocol, but according to the Convention on Biodiversity (CBD 1992), genetic material and genetic resources are defined as follows:
- "Genetic material" means any material of plant, animal, microbial or other origin containing functional units of heredity.
- "Genetic resources" means genetic material of actual or potential value. The same definition is used in the regulation (EU) No 511/2014 of the European Parliament and of the Council
In practice, this means any biological material, if research and/or product development is aimed at the genes it contains or the metabolic products derived from them. Different countries may have their own interpretation of what constitutes genetic resources. Currently, there are ongoing international negotiations on the inclusion of digital sequence information (DSI) related to genetic resources within the scope of the benefit sharing obligation.
Parties to the Nagoya Protocol
The countries (parties) that have ratified the Nagoya Protocol can be found in the international information sharing system (Access and Benefit Sharing Clearing-house; ABSCH). Some of the provisions related to compliance with the protocol have been implemented by the EU regulation (Regulation (EU) No. 511/2014 of the European Parliament and Council), which is binding on EU member states. Finland has brought the EU regulation into force with the Genetic Resources Act.
What is in the scope?
The Nagoya Protocol applies to the genetic resources of all organisms, except humans, from all its parties’ geographical areas. The agreement does not, however, cover Antarctica or international waters. Plant genetic resources are in the scope of the Nagoya Protocol, except those covered by the International Treaty on Plant Genetic Resources (ITPGRFA) Annex 1 and used for plant breeding. The requirement for obtaining prior consent applies to genetic resources acquired after October 2014 (when the protocol entered into force) and from countries that are parties to the protocol.
Not all Parties of the Protocol regulate access to their genetic resources. E.g. Finland's genetic resources are freely available for research and development. However, users of Sámi traditional knowledge (associated with genetic resources) must obtain prior informed consent.
Reports in Finnish related to the Nagoya Protocol
More information
Senior adviser, docent Katileena Lohtander-Buckbee, Finnish Environment Institute, tel. 0295 251 390, Katileena.Lohtander-Buckbee@syke.fi
Publisher