If you bring biological material to Finland from abroad for research and development purposes:
First, find out if the material is governed by the Nagoya Protocol. If yes, find out, if the material
If ALL of the aforementioned conditions apply to the material:
1 Acquire Prior Informed Consent (PIC) from national competent authority (CA) of the country of origin for using the genetic resource BEFORE collecting/utilising the material. You must also find out whether you need to negotiate Mutually Agreed Terms (MAT) with the competent authority (CA) or with a representative of the indigenous people. When contacting the authorities, you must state the intended use of the genetic resources. The national authorities of the provider country will send the granted Prior Informed Consent to the national ABS information exchange platform (ABS Clearing-House), from which an internationally recognised certificate of compliance (IRCC) can be acquired for the genetic resource. You will need to acquire either the abovementioned certificate or another certificate from the authority.
2 If you acquire the genetic resource from a previous user, you must also request the aforementioned documents and find out if the Mutually Agreed Terms must be renegotiated.
3 If the genetic resource’s intended use changes, for example from research to developing a commercial product, and the consent was only given for research activities, the Mutually Agreed Terms may have to be renegotiated.
4 Please note that the country may also require additional permits for collecting samples. Prior Informed Consent does not replace any other required permits (such as collection permit).
5 When you import genetic resources from a country requiring Prior Informed Consent for research and/or development activities, report* this to the competent authorities in Finland (SYKE and Luke) within one month of the date.
6 Keep the documents (Prior Informed Consent and Mutually Agreed Terms, if applicable) for 20 years after the use has ended.
7 Fill in and send the declaration about exercising due diligence through the EU’s DECLARE site when accepting research funding and/or during the finished product’s final development stages. You need to register in the European Commission Authentication Service (ECAS). Then you can enter to DECLARE with your ECAS id. If you have acquired the genetic resource from EU’s registered collection**, it is deemed that you have fulfilled the obligation of due diligence with regard to information acquisition.
The aforementioned applies to genetic resources and traditional knowledge which are part of the Nagoya Protocol’s scope of application. See the section ”The regulations’ scope of application”. The national laws and authorities can be found on the international information exchange platform (ABS Clearing-House). The site also has examples of best practices for acquiring genetic resources and model agreements for Mutually Agreed Terms (MAT). Mutually Agreed Terms are private law contracts.
Sharing benefits may include financial profits, but also e.g. research cooperation. Therefore, you may wish to find out if the utilisation of a genetic resource can be implemented in cooperation with the research institutes of the providing country.
*Import notifications (section 2) to the competent authorities are to be sent electronically via the website https://geenivararekisteri.ymparisto.fi/geenivararekisteri (Finnish genetic resource registry). If you have not received the internationally recognized certificate of compliance (IRCC), you must attach the information determined in Article 4, paragraph 3, of EU’s Genetic Resources Decree.
** When genetic resources are acquired from a collection that has been registered in accordance with Article 5 of EU Decree 511/2014, the user is deemed to have exercised due diligence in information search with regard to the genetic resources belonging to the collection in question. This means that the user of the genetic resource is not required to acquire the information defined in the Article 4, paragraph 3 of the Decree (for example, certificate of compliance). The owner of the registered collection is obligated to submit all the necessary data with the genetic resource. However, the user of the genetic resource is also obligated to store this information and to transfer it to potential subsequent users. Similarly, the user is still obligated to declare due diligence when accepting research funding or during the product’s final development stage. The notification must include the data supplied by the collection.
With regard to genetic resource acquired from a registered collection, if the intended use of the genetic resource changes, the user may have to apply for or update the Prior Informed Consent and establish Mutually Agreed Terms for the new intended use, if the Prior Informed Consent and Mutually Agreed Terms do not cover it. In such cases, the user must contact the competent authority of the providing country.
- Updated (06.11.2019)