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Interim National Reports on the Implementation of the Nagoya Protocol
(NR)
published: 30 Oct 2017
last updated: 19 Feb 2018
No country selected.
Interim national report on the implementation of the Nagoya Protocol
CHM-NFP-EU-210290-3
ABS National Focal Point
Ms. Mery Ciacci
This document has been updated. This is not the latest published version.
Click here to view the latest version of the record.
To view the current National Focal Point information, click
here.
Yes
Yes
No difficulties encountered.
No
There are no competent national authorities at EU level. Instead, individual EU Member States have established competent national authorities, both for the purpose of Article 13 and for the purpose of implementation of the EU ABS Regulation. For more detailed information, please consult reporting from the individual EU Member States.
No selection made
No selection made
There are no access measures established at EU level. Some EU Member States have established access measures at national level whereas others decided not to introduce specific ABS access measures. For information about access measures, please consult reports from the EU Member States.
Not applicable, since no access requirements are in place
No selection made
Yes
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 not placing disproportionate or unnecessary burdens on those concerned.
In the EU, two checkpoints are established (applicable in all Member States). Pursuant to Article 7(1) and 7(2) of Regulation 511/2014, competent authorities designated in Member States receive information as provided in Article 17(1) of the Protocol from the users in their jurisdiction. More specifically:
1st checkpoint: competent authorities designated by individual Member States under Regulation 511/2014 receive due diligence declarations from researchers carrying out research in the EU; all recipients of research funding in the form of a grant, where such research involves utilisation of genetic resources and traditional knowledge associated with genetic resources are to be requested either by the European Commission or by the Member State, to declare that they exercise due diligence; the template for this declaration is contained in the Commission Implementing Regulation in Annex II;
2nd checkpoint: competent authorities designated in Member States under Regulation 511/2014 gather due diligence declarations at the final stage of product development; 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 to above transfer the information to the ABS Clearing House, provided it is not confidential; alternatively, in case crucial information for publishing of a checkpoint communiqué (CPC) is indicated as confidential and a CPC can thus not be published, the authorities contact directly the competent national authorities of the country providing genetic resources.
Please consult information in Member States’ reports.
No additional information provided
Setting up of an institutional framework in the EU did not pose particular difficulties. The EU however has a specific legal framework due to its character as a regional economic integration organisation and the division of competences between the EU and the Member States. This is reflected in responses to many of the questions in this report.
No
There are no access measures established at EU level; Member States however may establish access measures at national level if they so wish.
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
Not applicable
No selection made
No access rules at EU level; not applicable.
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 terms, in accordance with any applicable legislation or regulatory requirements.”
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 terms, in accordance with any applicable legislation or regulatory requirements.”
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 terms, in accordance with any applicable legislation or regulatory requirements.”
No additional information provided
Yes
Yes
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 9 June 2014 and into application on 12 October 2014; some provisions entered into application on 12 October 2015;
Commission Implementing Regulation (EU) 2015/1866 laying down detailed rules for the implementation of Regulation (EU) 511/2014 as regards the register of collections, monitoring user compliance and best practices; entered into force on 9 November 2015.
Cases of non-compliance are dealt with at national level by individual Member States. Please consult reports of the EU Member States for more detailed information.
No
Please consult reporting of EU Member States for details on this point.
In the EU, where relevant competences are shared between the Union and its Member States, the legal measures concerning compliance are taken at EU level whereas Member States are responsible for the implementation of these measures; it is thus necessary to read the EU reporting together with the reporting submitted by EU Member States.
Yes
Yes
No
Please consult reporting from the EU Member States on specific cases.
Both the EU ABS Regulation (511/2014) and Commission Implementing Regulation (2015/1866) are applicable to genetic resources and to traditional knowledge associated with genetic resources; these Regulations provide for the legal framework for addressing any issues of non-compliance in the EU.
In the EU, where relevant competences are shared between the Union and its Member States, the legal measures concerning compliance are taken at EU level whereas Member States are responsible for the implementation of these measures; hence it is necessary to read the EU reporting together with the reporting submitted by EU Member States.
Yes
In line with Article 7(1) and 7(2) of Regulation 511/2014, users need to provide information as required by Article 17(1) of the Protocol to designated competent authorities in EU Member States. Annex II and III to the Commission Implementing Regulation provide for the specific information requested from users; this includes information related to PIC, to the source of the genetic resource, to the establishment of the MAT and to the utilisation of the genetic resources.
Yes
In addition to the above, competent authorities in EU Member States are obliged, based on Article 9 of Regulation 511/2014, to perform checks on user compliance in accordance with periodically revised risk-based plans. Please consult reporting from EU Member States for more detailed information on this point.
No
Not selected
Further information: The competent authorities in the Member States are responsible for providing this information to relevant national authorities in the Party granting PIC and to the ABS Clearing-House, in the form of checkpoint communiqués. Please consult the reporting from EU Member States for more precise information.
No
Please consult reporting of the Member States. No measures taken in this regard at EU level.
Yes
Article 13 of Regulation 511/2014 obliges both the European Commission and EU 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.
An EU-wide web-based application is being developed for the users to submit due diligence declarations electronically to the competent authorities. The portal will be connected to the ABS Clearing House, thus allowing competent authorities to transfer information in a cost-effective way.
No additional information provided
Making operational the definitions enshrined in the Protocol, especially the definition of utilisation, remains a challenging aspect of the Protocol’s implementation.
Not applicable, since no access requirements are in place
No selection made
No
Recourse to legal systems in cases of disputes arising from MAT is not dealt with at EU level; recourse is however available under the legal systems of individual Member States. Please consult reporting from the Member States for more detailed information on this point.
No
Access to justice in disputes over contractual agreements is not dealt with at EU level but provided by individual Member States; please consult reporting from the Member States for more detailed information on this point.
No
This is not dealt with at EU level but provided by individual Member States. Please consult reporting from the Member States for more detailed information on this point.
No additional information provided
Yes
There are no access measures at EU level hence there are also no simplified measures on access for non-commercial research purposes.
However, Article 16 of the EU ABS Regulation requires the European Commission to review the functioning and effectiveness of the Regulation in achieving the objectives of the Nagoya Protocol. In this review the European Commission needs to consider the administrative consequences inter alia for public research institutions.
Yes
There is no access legislation at EU level hence there are also no measures on expeditious access to genetic resources for that purpose. Article 4(8) of Regulation 511/2014 however provides for a short temporal derogation from the duties of its Articles 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.
No
There are no access rules at EU level hence there are also no specific measures for expeditious access and expeditious benefit-sharing.
Yes
There are no access rules at EU level hence there are also no specific measures concerning genetic resources for food and agriculture.
Recital 12 of Regulation 511/2014 however recalls Article 8(c) of the Protocol and explains that ITPGRFA is a specialised instrument within the meaning of Article 4(4) of the Protocol. The Regulation also recognises that, where Parties have decided to use standard material transfer agreements for plant genetic resources for food and agriculture (PGRFA) which are not covered by ITPGRFA but which are under their control and in the public domain, no due diligence declaration is required.
No additional information provided
No
For information concerning indigenous and local communities please consult reporting from EU Member States. There are no measures concerning indigenous and local communities at EU level.
Not applicable
No selection made
No selection made
Not applicable
Not applicable
Not applicable
Not applicable
No selection made
No selection made
No selection made
Not applicable
Not applicable
No additional information provided.
Yes
In line with Article 13 of Regulation 511/2014, the European 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.
The European Commission, when assessing applications for recognition of best practices (see response to question no. 52), encourages the applicants to incorporate this aspect into their proposed best practice.
No answer provided
No additional information provided.
No
There is no access legislation at EU level; please consult reporting of the Member States which established access measures for further details on this point.
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 European Commission and the Member States shall encourage the 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.
The European Commission has also engaged in the organization of a workshop with selected Nagoya Protocol Parties, including countries with access legislation in place, EU Member States’ competent authorities and user representatives. One aspect which will be discussed during the workshop is model contractual clauses for MAT.
Yes
Article 8 of Regulation 511/2014 provides that associations of users or other interested parties may submit an application to the European Commission to have a combination of procedures, tools or mechanisms recognized as best practice. Details concerning the application and the process of recognition are laid down in the Commission Implementing Regulation.
The European Commission has so far received 3 applications for recognition as a best practice and is in dialogue with the applicants to make sure that the applications fulfil the standards set up in the EU ABS Regulation and the Commission Implementing Regulation.
Furthermore, in line with Article 13 of Regulation 511/2014, the European Commission and Member States shall encourage the development of sectorial 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.
In line with this obligation, the European Commission has engaged in the preparation of guidance for "upstream" users (academics, universities, non-commercial research, and collections) as well as sectorial guidance aimed to assist various sectors which utilise genetic resources in better understanding of their duties stemming from the Regulation.
No additional information provided
Yes
Yes
The European Commission has organised a series of workshops aimed at raising awareness of academia and non-commercial researchers in various EU cities throughout the years 2015-2016 (5 workshops in 2015 and 4 in 2016).
European Commission representatives have also participated in numerous conferences and workshops presenting the EU ABS Regulation and informing various stakeholders about the duties stemming from the Nagoya Protocol and the EU ABS Regulation (30 events over a period of 4 years; 2014-2017).
Yes
Yes
The European Commission developed guidance on the scope of application and core provisions of the EU ABS Regulation to build the capacity in the EU in implementing the Protocol.
European Commission representatives participated in numerous trainings, meetings and workshops (including in-house) to build understanding of the Protocol and strengthen the (institutional) capacity to effectively implement it.
No
Yes
The European Commission provides significant support on behalf of the EU to many ABS-related projects:
- on-going support (EUR 556,000 EU contribution for the period 2014-2017) to the CBD Secretariat for the implementation of the Protocol (such as ABS Clearing House development, capacity building workshops, etc.);
- support to developing countries in the framework of the ABS Capacity-Building Initiative (phase I, EUR 5 million EU contribution, covering the period 2011-2015);
- support to African-Caribbean-Pacific (ACP) countries for accession and ratification of the Protocol (EU-ACP MEAs Phase II, via UNEP).
No additional information provided
Yes
The European Commission provides support on behalf of the EU to many research and development programmes contributing thus to technology transfer and collaborating in technical and scientific research & development programmes.
Working Programmes in the EU’s current main instrument for funding of research & innovation (R&I) “Horizon 2020” strongly encourage international participation in consortia, and the number of topics flagged as particularly relevant for international cooperation has significantly increased over time. Applicants from 188 countries in total have applied and participants from 131 countries have been funded (including EU, associated and non-associated third countries) over the first two years of implementation of Horizon 2020. During the same period, several co-funding mechanisms have been negotiated by the European Commission with different key country partners.
The European Commission is also leading multilateral R&I partnerships addressing global challenges in areas such as health, food, energy, water, climate change and the circular economy. For example, in response to the Zika outbreak in the Latin America and Caribbean region, the European Commission launched several research projects totalling more than EUR 35 million. The EU is also providing up to EUR 683 million for the second European and Developing Countries Clinical Trials Partnership under which 14 European and 14 African countries are supporting collaborative research that accelerates the clinical development of new or improved interventions to prevent or treat HIV/AIDS, tuberculosis, malaria and neglected infectious diseases in sub-Saharan Africa.
The European Commission has also supported sustainable and equitable development by providing significant resources for addressing the scientific divide and strengthening the science and technology capacities of lower middle-income economies. This has encouraged regional and international R&I networks to create synergies between main actors in the innovation value chain in these countries and to increase their institutional R&I capacities. Notably, the European Development Fund has contributed to three successive intra-ACP research capacity programmes worth EUR 70 million in total. With an indicative allocation of EUR 60 million, the EU has renewed its commitment until 2020 to upgrade the ACP's research capability and improve skill development systems to support innovation. In parallel, EUR 17.5 million in African Research Grants are promoting R&I along the food value chain.
The results of EU-funded R&I have thus contributed to the development and implementation of a number of international commitments, including the Convention on Biological Diversity, the Nagoya Protocol, the 2030 Agenda for Sustainable Development, and many others.
No additional information provided
No particular challenges encountered.
No
The implementation of the Protocol and the costs associated with it are a responsibility of the EU Member States; hence this information needs to be obtained from the Member States’ reports.
Yes
See response to question 57; in addition, the EU Member States made financial resources available to the Global Environment Facility.
No information provided
No information provided
Yes
Less than 5
No information provided
Question 3: comment under section ‘yes’ is unclear;
Question 4: the requirement to provide a summary of the main difficulties and challenges encountered in setting up these measures seems wrongly placed and is attached to situations where no such measures are adopted rather than to situations when they are adopted; the question seems however to be applicable rather to situations where such measures were adopted.
In the section “Legislative, administrative or policy measures on access and benefit-sharing (ABS measures)” for sub-sections “Access to genetic resources (Article 6)” and “Benefit sharing (Article 5)” there should be a possibility to skip the whole section in case no access and benefit measures are established rather than explaining this in response to each question;
Question 27: the “no” option is missing (added by us in the current report).
The reporting format is partly not suitable for reporting from international organisations such as EU.
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