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Yes
Yes
No major difficulties
Regulation (EU) 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union;
Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) 511/2014 as regards register of collections, monitoring user compliance and best practices;
Commission Notice – Guidance document on the scope of application and core obligations of Regulation (EU) 511/2014 (2016/C 313/1)
Act no 1375 23/12/2012 on sharing benefits arising from the utilisation of genetic resources
Executive order no 867 25/06/2017 on the entry into force of the Act on sharing benefits arising from the utilization of genetic resources and penalties for violation of the Regulation (EU) 511/2014.
Not applicable, since no access requirements are in place
No selection made
Yes
Pursuant to Article 7(1) and (2) of Regulation 511/2014 designated competent authorities receive information as provided in Article 17(1) of the Protocol from users within their jurisdiction.
In Denmark, the competent authority designated is: Environmental Protection Agency, Ministry of Environment and Food
More specifically, there are two checkpoints in Denmark, as established at EU level:
1st checkpoint: competent authorities designated under Regulation 511/2014, i.e. Environmental Protection Agency, Ministry of Environment and Food receive due diligence declarations from researchers; all recipients of research funding, where such research involves utilisation of genetic resources and traditional knowledge associated with genetic resources, are requested either by the European Commission or by the Member State as providers of funding, to declare that they exercised due diligence; the template for this declaration is contained in the Commission Implementing Regulation in Annex II;
2nd checkpoint: competent authorities designated under Regulation 511/2014, i.e. Environmental Protection Agency, Ministry of Environment and Food gather due diligence declarations at the final stage of a product development from all users; the template for this declaration is contained in the Commission Implementing Regulation in Annex III; specific events triggering submission of the declaration are defined in Article 6 of the Commission Implementing Regulation.
For both checkpoints, the authorities referred above transfer the information to ABS Clearing House, provided it is not confidential; alternatively, in case crucial information for publishing of checkpoint communiqué (CPC) is indicated as confidential and CPC cannot be published, the authorities contact the competent national authorities of the country providing genetic resources.
The main challenge in defining the checkpoints in the EU was striking a balance between having effective checkpoints covering the full range of relevant ABS activities, while avoiding creating an unnecessary administrative burden.
Users are obliged to comply with any other national regulation in Denmark
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
No selection made
Not applicable, since no access requirements in Denmark. Users are however obliged to comply with any other national regulation in Denmark.
No additional information provided
Yes
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed tersm, in accordance with any applicable legislation or regulatory requirements."
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed tersm, in accordance with any applicable legislation or regulatory requirements.”
Article 4(1) of the EU ABS Regulation provides that “users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed tersm, in accordance with any applicable legislation or regulatory requirements.”
Regulation (EU) 511/2014 on compliance measures for the users from the Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union; entered into force on 12 October 2014;
Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) 511/2014 as regards register of collections, monitoring user compliance and best practices; entered into force on 9 November 2015;
Executive order no 867 25/06/2017 on the national authority for the administration of the Act on sharing benefits arising from the utilization of genetic resources and penalties for violation of the Regulation (EU) 511/2014
Both the EU ABS Regulation (511/2014) and Commission Implementing Regulation (2015/1866) are applicable to genetic resources and to traditional knowledge associated with the genetic resources; these Regulations provide for the legal framework to deal with issues of non-compliance.
The Danish Act on sharing benefits arising from the utilisation of genetic resources and the executive order no 867 of 25/06 2017 are applicable to genetic resources and the traditional knowledge associated with the genetic resources in provider countries.
In line with Article 7(1) and (2) of Regulation 511/2014, users need to provide information as required by Article 17(1) of the Protocol
Annexes II and III to the Commission Implementing Regulation. Information is requested from researchers and end-users respectively; this includes information related to PIC, the source of genetic resource, the establishment of MAT and the utilisation of genetic resources.
Yes
In addition to the above, competent authorities in Denmark are obliged, based on Article 9 of Regulation 511/2014, to perform checks on user compliance in accordance with a periodically revised risk-based plan.
Article 13 of Regulation 511/2014 obliges the Commission and Member States, as appropriate, to promote the development and use of cost-effective communication tools and systems in support of monitoring and tracking the utilisation of genetic resources and traditional knowledge associated to genetic resources by collections and users.
Denmark has established an ABS Website with information for users: http://mst/abs-protokollen/
No additional information provided
Not applicable, since no access requirements are in place
No
Yes
Under Danish law foreign States as well as persons or legal persons have legal standing and full access to justice on the same basis as Danish legal subjects. Danish legal assistance programs do not discriminate between Danes and foreigners.
Yes
Under Danish law foreign States as well as persons or legal persons have legal standing and full access to justice on the same basis as Danish legal subjects. Danish legal assistance programs do not discriminate between Danes and foreigners.
Yes
Under Danish law foreign States as well as persons or legal persons have legal standing and full access to justice on the same basis as Danish legal subjects. Danish legal assistance programs do not discriminate between Danes and foreigners.
No additional information provided
No
Yes
Article 4(8) of Regulation 511/2014 provides for a short temporal derogation from the duties of its Article 4(3) and 4(5) for users acquiring a genetic resource that is determined to be, or is determined as likely to be, the causing pathogen of a present or imminent public health emergency of international concern.
Article 4(8) of Regulation 511/2014 provides for a short temporal derogation from the duties of its Article 4(3) and 4(5) for users acquiring a genetic resource that is determined to be, or is determined as likely to be, the causing pathogen of a present or imminent public health emergency of international concern.
Recital 12 of Regulation 511/2014 recalls Article 8(c) of the Protocol and explains that the ITPGRFA is a specialised instrument within the meaning of Article 4(4) of the Protocol. The Regulation also recognises that where Parties to the Protocol have decided to use the standard material transfer agreement for plant genetic resources for food and agriculture which are not covered by ITPGRFA, but which are under their control and management and in public domain, submission of due diligence declarations is not required.
In line with Article 13 of Regulation 511/2014, the Commission and the Member States shall encourage users and providers to direct benefits from the utilisation of genetic resources towards the conservation of biological diversity and the sustainable use of its components in accordance with the provisions of the Convention.
Denmark has continuously encouraged users and providers to use the benefits from ABS agreements for conservation of biological diversity and the sustainable use purposes. It has inter alia been articulated by Danish Ministers of the Environment and Food expressed in speeches at MOP1 and MOP2 as well as at the four International ABS Business Dialogues in Copenhagen.
No answer provided
Inter alia by supporting financially the ABS Capacity Development Initiative including 4 International ABS Business Dialogue meetings
https://www.cbd.int/doc/meetings/abs/abscbiac-2016-01/other/abscbiac-2016-01-presentation-abs-initiative-en.pdf
http://www.abs-initiative.info/countries-and-regions/global/denmark/4th-abs-business-dialogue-public-private-partnerships-for-sustainable-development/
http://www.abs-initiative.info/countries-and-regions/global/denmark
No additional information provided.
No
Not applicable, since there are no indigenous and local communities in my country
No selection made
No additional information provided
Yes
In line with Article 13 of Regulation 511/2014, the Commission and the Member States shall encourage development of codes of conduct, model contractual clauses, guidelines and best practices, particularly when they would benefit academics, university and non-commercial researchers and small and medium-sized enterprises.
National stakeholders receive information about the abovementioned development at the national stakeholder meetings (1-4 meetings annually).
In line with Article 13 of Regulation 511/2014 the Commission and the Member States shall encourage development of sectoral codes of conduct, model contractual clauses, guidelines and best practices, particularly when they would benefit academics, university and non-commercial researchers and small and medium-sized enterprises.
National stakeholders receive information about the abovementioned development at the national stakeholder meetings (1-4 meetings annually).
National stakeholder meetings (1-4 meetings annually), 4 International ABS Business Dialogues 2010-2016.
Communication by e-mail and bilateral meeting with stakeholders in the following sectors: biotech, food and feed, cosmetics, pharmaceuticals, plant breeding and universities.
Awareness raising by communicating on official website: http://mst.dk/abs-protokollen/
Yes
Yes
Financial support to the ABS Capacity Development Initiative. Denmark has contributed to the ABS Capacity Development Initiative from 2010-2016 and thereby strengthening human resources and institutional capacities in Africa.
Denmark has contributed to the ABS Capacity Development Initiative from 2010-2016 and thereby to building and developing capacity in Africa incl. hosting 4 International ABS Business Dialogue 2010-2016
http://www.abs-initiative.info/countries-and-regions/global/denmark/4th-abs-business-dialogue-public-private-partnerships-for-sustainable-development/
http://www.abs-initiative.info/countries-and-regions/global/denmark
https://www.cbd.int/doc/meetings/abs/abscbiac-2016-01/other/abscbiac-2016-01-presentation-abs-initiative-en.pdf
No additional information provided
Yes
Denmark has contributed to the ABS Capacity Development Initiative from 2010-2016 and thereby to capacity building in Africa
http://www.abs-initiative.info/countries-and-regions/global/denmark/4th-abs-business-dialogue-public-private-partnerships-for-sustainable-development/
http://www.abs-initiative.info/countries-and-regions/global/denmark
https://www.cbd.int/doc/meetings/abs/abscbiac-2016-01/other/abscbiac-2016-01-presentation-abs-initiative-en.pdf
