If you work with genetic resources or traditional knowledge (TK) of other countries, you might need to comply with the requirements of the Convention on Biological Diversity (CBD) and the Nagoya Protocol. For the overall understanding of the further procedure, please see the information below.
To understand better if you should be concerned about the use of genetic resources and traditional knowledge in your research project, please follow these steps and use the checklist.
Useful acronyms
ABS - Access and Benefit Sharing
Basic category for efficient and ethical usage of genetic resources and TK
CBD - Convention on Biological Diversity
MAT - Mutually Agreed Terms
Contains the benefit a providing country gets for the use of genetic resources and TK
PIC - Prior Informed Consent
Must be obtained from the providing country to get access to genetic resources or TK
How to get access to genetic resources and TK according to Nagoya Protocol?
The CBD establishes common standards of ABS for all the signatory parties. However, you need to contact a specific country directly to obtain a PIC and negotiate the relevant MAT. In order to do this, you need to go to the website of Access and Benefit-sharing Clearing-House and pick your providing country, see the contact information for the ABS national focal point and the competent national authority.
Then you need to file your PIC request and negotiate the MAT with the providing country.
Request for PIC must contain the nature and research goal for utilization.
The procedure only applies to genetic resources from provider countries which are Parties to the Nagoya Protocol and have established applicable access measures.
In case you are using genetic resources and TK from a providing country that is not signatory of the Nagoya Protocol, you will need to contact the respective country individually and seek for permission to use such genetic resources.
In case your research involves the use of genetic resources and TK – please contact the Head of Department or the SDU legal advisor to receive help with filing a request for PIC.
How can I comply with requirements of Nagoya Protocol?
Obligations of compliance are established in the EU Regulation ‘Responsibilities of research institutions and of researchers employed’
Both – academic institution and its employees – are responsible to comply with the requirements of Nagoya Protocol.
The requirements under the EU ABS Regulation concern also the actions of visiting scientists and students who may introduce genetic resources of foreign origin, often their home country, for research purposes and carry out research and development within the organisation.
The organisation is therefore advised to conclude a formal agreement with the visitor setting out
(i) who has the responsibility to ensure that due diligence has been done in regard to the material being utilised;
(ii) who has responsibility to submit a due diligence declaration, if required.
Stages of compliance
Before the start of your project check with the list of genetic resources and TK to be sure if you are using or not the genetic resources and traditional knowledge associated with genetic resources.
If you see that you will be using them in your project – make sure to comply with all the regulations and obtain a PIC from the respective providing country.
Reference
Detailed analysis of what resources are covered by Nagoya Protocol can be found in the Guidance document.
Even if you obtain genetic resources indirectly, through an intermediary such as a culture collection or other specialised companies or organisations with a similar function (a company or a collaboration partner), you should ensure that prior informed consent was obtained and mutually agreed terms were established by the intermediary when the resources were originally accessed.
You may need to obtain new PIC and conclude a new MAT or modify the existing ones, if the intended use is not covered by the PIC and MAT obtained and relied upon by the intermediary.
References
For more details about working with intermediaries see article 2.1.3. Indirect acquisition of genetic resources of the Guidance document.
When a research project involving utilisation of genetic resources and TK is subject to external funding in the form of a grant (for both public and private funding).
The Regulation stipulates two kinds of Due diligence Declarations:
1. declaration at the stage of research funding (art.5)
2. declaration at the stage of final development of a product (art.6)
The declaration at the stage of research funding needs to be made after the first instalment of funding has been received and all the genetic resources and traditional knowledge associated with genetic resources that are utilised in the funded project have been obtained, but in any case no later than at the time of the final report (or in absence of such report, at the project’s end).
References
The declarations need to be made according to the procedure outlined in the Commission implementing Regulation and using templates in Annexes 2-4.
There is a fast way to submit a due diligence declaration through the EU portal DECLARE.
You can use the user’s guide for DECLARE to get started.
Where genetic resources are obtained from a collection registered (entirely or partly) under Article 5 of the Regulation, the user is considered to have exercised due diligence as regards the seeking of information as far as resources from (the relevant, registered part of) that collection are concerned.
References
Article 3.7. Obtaining genetic resources from registered collections of the Guidance document.
Contact the National focal point and Competent national authority to submit a request for a PIC and offer a draft of MAT for negotiations with the providing country.
Access and Benefit-sharing Clearing-House is also involved into this procedure.
Contact the Head of department and your SDU legal advisor for assistance.
References
Model contractual clauses, codes of conduct, guidelines and best practices and/or standards can be found here.
Due diligence can be demonstrated with reference to an internationally recognised certificate of compliance (IRCC) which is either issued for the user in question, or the user can rely on it because the particular utilisation is covered by the terms of the IRCC.
If an IRCC is not available users must seek the information and acquire the relevant documents:
• The date and place of access to genetic resources or TK,
• The description of the genetic resources or TK,
• The source from which the genetic resources or TK were directly obtained,
• The presence or absence of rights and obligations relating to access and benefit-sharing (including rights and obligations regarding subsequent applications and commercialisations),
• Access permits, where applicable,
• Mutually agreed terms, where applicable.
The Danish Minister for the Environment and persons authorised by the Minister shall, upon presentation of appropriate ID, have the right of access without court order to public and private properties and sites in order to exercise the powers provided by this Act or in regulations issued in accordance with this Act.
Wherever possible, prior notification shall be given to the owner or user.
References
Article 4(3)(a) of the Regulation
Article 4(3)(b) of the Regulation
Danish Act on sharing benefits arising from the utilisation of genetic resources
Users are obliged to retain any information relevant for access and benefit-sharing for a 20 year period after the end of the period of utilisation.
References
Article 4(6) of the Regulation
What happens if I don’t comply?
Consequences for non-compliance with requirements of Nagoya Protocol and relevant legislation can be legal and non-legal (academic).
1. Legal consequences:
According to the Danish Executive order unless higher punishment is implied by other legislation, a fine shall be imposed on anyone who violates the requirements of due diligence.
If the violation was committed deliberately or because of negligence, or if a financial gain was achieved or intended for the violator himself or for others, the punishment may increase to up to two years of imprisonment.
Legal entities (such as SDU) may be punishable in accordance with the rules in Chapter 5 of the Danish Penal Code.
If seizure of proceeds from the violation was not made, the size of an achieved or intended financial gain must be taken into consideration when fixing the fine, cf. Paragraph 2.
The period of limitation for criminal liability is 5 years.
Persons and entities in violation of rules for legal use of genetic resources and TK may be also sanctioned according to the providing country’s local legislation.
2. Academic consequences:
Besides bad reputation in academic circles, researchers in violation of Nagoya Protocol and relevant legislation may encounter difficulties publishing papers that contain research results obtained regarding the genetic resources and TK without legal authorization.
Even if published, the academic papers violating Nagoya Protocol may be retracted in some cases.
Legislation
The conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding.
Information and link
Jurisdiction: International
Entered into force: 29 December 1993
Full text in English: https://www.cbd.int/convention/text/
The fair and equitable sharing of the benefits arising from the utilization of genetic resources.
Information and link
Jurisdiction: InternationalAdopted on 29 October 2010 and entered into force on 12 October 2014
Short outline of Nagoya Protocol can be found here.
Full text in English: https://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf
Establishes rules governing compliance with access and benefit-sharing for genetic resources and traditional knowledge associated with genetic resources in accordance with the provisions of the Nagoya Protocol.
Information and link
Jurisdiction: EU
of 16 April 2014
Full text in all languages of EU countries: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0511
Information and link
Jurisdiction: EUCurrent status of the measure: Not legally binding
Date of adoption: 14 Dec 2020
Full text in all languages of EU countries: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.C_.2021.013.01.0001.01.ENG&toc=OJ%3AC%3A2021%3A013%3ATOC
Contains instructions on how to file a Declaration of due diligence in case of external funding.
Information and link
Jurisdiction: EUOf 13 October 2015
Full text in English: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32015R1866&from=EN
The Danish Environmental Protection Agency shall monitor and ensure compliance with the rules of the regulation and of the implementing regulation.
In cases of non-compliance – there can be imposed administrative or criminal liability.
Information and link
Jurisdiction: DenmarkDate of entry into force: 15 Jul 2017
Information on the document and full text in Danish and English: https://absch.cbd.int/en/database/MSR/ABSCH-MSR-DK-238543-1
Information and link
Jurisdiction: DenmarkDate of entry into force: 12 Oct 2014
Information and text in Danish and English: https://absch.cbd.int/en/database/MSR/ABSCH-MSR-DK-204147-2
Nagoya Protocol finds implementation in specific countries through national legislations.
Access and Benefit-sharing Clearing-House is a web based platform to share information to support the implementation of the Nagoya Protocol. It contains direct information from the countries signatory to CBD and Nagoya Protocol regarding the measures for their implementation and all the relevant information.
Information about Denmark
Denmark (official country profile with the important information on the website of Access and Benefit-sharing Clearing-House).
The authority in Denmark: Ministry of the Environment of Denmark, Environmental Protection Agency
Ms. Eva Juul Jensen, Senior Policy Advisor, Nature Protection Unit, Danish Environmental Protection Agency
Haraldsgade 53, Copenhagen, DK-2100, Denmark
Phone: +45 93587949, Email: ejj@mst.dk