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Yes
Yes
The main difficulty encountered is that the measures will lead to increased costs and regulatory burden for users of genetic resources. Various meetings have been held with stakeholders regarding the consequences of the legislative proposal in actual practice.
EU level:
1. 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;
2. 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;
3. Commission Notice – Guidance document on the scope of application and core obligations of Regulation (EU) 511/2014 (2016/C 313/1).
National level:
4. For the implementation of the Nagoya Protocol and EU Regulation 511/2014 in the Netherlands, the Nagoya Protocol (Implementation) Act was enacted. The Nagoya Protocol (Implementation) Act contains definitions (Article 1), and deals with the implementation (Articles 2 and 3), the designation of competent authorities (Article 4), sanctions and other measures (Articles 5, 6, 7 and 8), the entry into force (Article 9), and the name of the law (Article 10).
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 the Netherlands, the competent authority designated is: the Netherlands Food and Consumer Product Safety Authority (NVWA) .
More specifically, there are two checkpoints in the Netherlands, as established at EU level:
1st checkpoint: competent authorities designated under Regulation 511/2014, i.e. the Netherlands Food and Consumer Product Safety Authority (NVWA), 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. the Netherlands Food and Consumer Product Safety Authority (NVWA), 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 unnecessary administrative burden.
No
Section 6.2.1 of the explanatory memorandum accompanying the Nagoya Protocol (Implementation) Act states that: "In the policy memorandum “Sources of Existence: Conservation and the sustainable utilisation of genetic diversity (2002)”, the then Government considered that it is not necessary to embed the national sovereignty of the Netherlands regarding access to and utilisation of genetic resources in legislation because the Netherlands is the country of origin for only a few species. The current Government shares that view. The present legislative proposal does not therefore further regulate access to Dutch genetic resources. Access to genetic resources is restricted, however, by means of legislation and regulatory requirements in the area of species protection, territorial protection, and animal and plant diseases."
Regulation (EU) 511/2014 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. Article 4(1) states 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". Article 2(1) of the Dutch Nagoya Protocol (implementation) Act states that it is prohibited to act in breach of such provisions of EU regulations concerning genetic resources as are designated by ministerial order. The Dutch Nagoya Protocol (implementation) Act provides for sanctions and other measures.
Regulation (EU) 511/2014 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. Article 4(1) states 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". Article 2(1) of the the Dutch Nagoya Protocol (implementation) Act states that it is prohibited to act in breach of such provisions of EU regulations concerning genetic resources as are designated by ministerial order. The Dutch Nagoya Protocol (implementation) Act provides for sanctions and other measures.
Regulation (EU) 511/2014 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. Article 4(1) states 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". Article 2(1) of the Dutch Nagoya Protocol (implementation) Act states that it is prohibited to act in breach of such provisions of EU regulations concerning genetic resources as are designated by ministerial order. The Dutch Nagoya Protocol (implementation) Act provides for sanctions and other measures.
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;
The Nagoya Protocol (Implementation) Act entered into force on 23 April 2016. Articles 5, 6, 7 and 8 of the Nagoya Protocol (Implementation) Act deal with sanctions and other measures. Article 6, paragraph 4, of the explanatory memorandum accompanying the Nagoya Protocol (Implementation) Act deals with enforcement, including monitoring authorities (6.4.1) and sanctions and other measures (6.4.2);
The Regulation of the Minister for Agriculture of 31 March 2016, No. WJZ/15145152, laying down provisions in implementation of the Nagoya Protocol Implementation Act (Regulation in implementation of the Nagoya Protocol Implementation Act) entered into force on 23 April 2016. Article 1 of this Regulation designates the articles of EU Regulation 511/2014 and EU Implementing Regulation 2015/1866 which can be enforced under criminal law. These articles concern the compliance of users of genetic resources with the due diligence requirements and its enforcement. Any conduct in contravention of the provisions is designated as an economic offence.
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.
At the national level, both the Nagoya Protocol (Implementation) Act and Regulation WJZ/15145152 are applicable to genetic resources as well as traditional knowledge associated with genetic resources.
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 to competent authorities designated in [name of the country]. Annexes II and III to the Commission Implementing Regulation provide for the list of information requested from researchers and end-users respectively; this includes also information related to PIC, the source of genetic resource, to the establishment of MAT and to utilisation of genetic resources.
Yes
In addition to the above, competent authorities in the Netherlands 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.
Not applicable, as no due diligence declarations have been submitted yet to the checkpoints.
No
Yes
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 trditional knowledge associated by genetic resources by collections and users.
We use DECLARE (an EU-wide web-based data submission portal for users to submit due diligence declarations electronically).
No additional information provided
Not applicable, since no access requirements are in place
No selection made
Yes
As indicated in Annex 1 of the Explanatory Memorandum of the Nagoya Protocol (Implementation) Act, Article 18 does not require implementation in the framework of the Nagoya Protocol, as this provision is already implemented by existing law.
As indicated in Annex 1 of the Explanatory Memorandum of the Nagoya Protocol (Implementation) Act, Article 18 does not require implementation in the framework of the Nagoya Protocol, as this provision is already implemented by existing law.
Yes
As indicated in Annex 1 of the Explanatory Memorandum of the Nagoya Protocol (Implementation) Act, Article 18 does not require implementation in the framework of the Nagoya Protocol, as this provision is already implemented by existing law.
There are no access regulations in the Netherlands, hence conditions have been created to promote and encourage research which contributes to the conservation and sustainable use of biodiversity.
With respect to access measures: there are no access regulations in the Netherlands, hence due regard is paid to cases of present or imminent emergencies .
With respect to compliance measures (established at the EU level): 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.
With respect to access measures: there are no access regulations in the Netherlands, hence the importance of genetic resources for food and agriculture and their special role for food security has been considered.
With respect to compliance measures (established at the EU level): 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.
Not applicable, as there are no access regulations in the Netherlands.
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.
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.
- A bilingual NFP website has been established to inform the public of ABS and the Nagoya Protocol.
- Stakeholders' meetings with representatives of a range of user groups are organized at regular interviews.
- Presentations on the Protocol are given by the CNA, the NFP and the NVWA.
- The NFP sends out mailings to inform users of genetic resources of milestones (e.g. the ratification of the Nagoya Protocol by the Netherlands).
- Stakeholders' meetings with representatives of a range of user groups are organized at regular interviews.
- Presentations on the Protocol are given by the CNA, the NFP and the NVWA.
No
Yes
The Government of the Netherlands has supported several bilateral projects focusing on the implementation of access and benefit-sharing legislation and regulations in a number of countries including China, India (government to government), Kenya, Burkina Faso, South Africa and Namibia (stakeholder parties in-country).
The Centre for Development Innovation (CDI) and the Centre for Genetic Resources, the Netherlands (CGN) of Wageningen UR annually organize short-term post-graduate courses on plant genetic resources conservation, use and policies. Participants are supported by the Dutch Ministries of Economic Affairs and Foreign Affairs (through NUFFIC).
