As research funding provider or product approval authority you play a key role as information disseminator and link to users of genetic resources.
You can contribute to the effective implementation of the ABS Regulation by informing the users of the requirements imposed upon them in conjunction with the assignment of public or private research funding and the final stage of product development.
Information to be disseminated
You may disseminate the following information in conjunction with the announcement of research funding and prior to the final approval of a product. Links can be found under the "Laws/Regulations" tab, above.
- The ABS Regulation applies to all genetic resources except:
- the human genome
- genetic resources that fall outside the sovereign rights of a country, e.g. marine areas outside national jurisdiction (international waters) and areas covered by the Arctic treaty
-genetic resources for food and agriculture used within the framework of the International Treaty on Plant Genetic Resources for Food and Agriculture and
-Influenza preparedness framework for influenza virus with pandemic potential, the so called PIP framework (Pandemic Influenza Preparedness
- The ABS Regulation applies on the condition that the access country is a party to the Nagoya Protocol and that the county has national access legislation.
- The ABS Regulation is applicable to accesses to genetic resources carried out after 12 October 2014.
- Further information regarding time and the procedure for making a declaration in conjunction with the assignment of research funding and in conjunction with the final approval of a product is given in Article 5 and Article 6, respectively, of the ABS Implementation Regulation (EU) 2015/1866.
- Spot checks of users’ compliance will be conducted by the Swedish Environmental Protection Agency in accordance with a risk-based control plan.
- The user must clearly mark, in his or her declaration, any information that is confidential.
Declaring due diligence
You must show that you comply with the access legislation of the country in question. You must show this by obtaining prior informed consents (PIC) and establishing mutually agreed terms (MAT) and by declaring due diligence in accordance with the ABS Regulation.
You must submit a due diligence declaration on two occasions:
- after the first partial payment of research funding has been received or not later than the end of the project or when the final report is submitted. This applies even if no further product development occurs.
- in the final development stage of a product.
You must submit your declaration of due diligence using the data submission tool “DECLARE”. Articles 5-6 of the EU’s Implementation Regulation contain more detailed information about when to submit declarations. The procedure for submitting a declaration can be found in the User Guide for the DECLARE NAGOYA IT system.
NB: Concerning due diligence
The Swedish Environmental Protection Agency requests that all recipients of research funding (Article 7.1 of EU Regulation No. 511/2014), that pertains to the use of genetic resources and traditional knowledge concerning such resources, must declare due diligence.
On 12 October 2014 the Nagoya Protocol and the EU ABS Regulation came into effect. This implies that anyone who conducts research on genetic resources and traditional knowledge about such resources must have permission for the use of such material (PIC) and must have established an agreement (MAT) as to how the research will benefit the host country. Any user who has accessed genetic resources and traditional knowledge after 12 October 2014 is required to declare so-called due diligence.
Due diligence implies that the user must show that the genetic resource was obtained in accordance with applicable legislation in the country in question and that the potential benefit of the genetic resource must be distributed in a reasonable and fair manner. Exceptions are research on the human genetic heritage, pandemic influenza virus that is covered by the WHO’s PIP framework, genetic material that has been obtained from international waters, and plant genetic material that is included in Appendix 1* of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGFA). For any questions concerning the regulations and the declaration of due diligence, please contact the Swedish Environmental Protection Agency.
Use of links encouraged
We encourage the use of links from your website to the Swedish Environmental Protection Agency’s information.