Federal Ministry for the Environment, Climate Protection, Nature Conservation and Nuclear Safety

Federal Agency for Nature Conservation

There are two checkpoints in Germany, as established at EU level (Article 7 Regulation (EU) Nr. 511/2014): 1st checkpoint: competent authorities designated under Regulation (EU) No 511/2014, i.e. the Federal Agency for Nature Conservation 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 No 511/2014, i.e. the Federal Agency for Nature Conservation 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 the submission of both checkpoints, the online tool DECLARE by the EU Commission can be used; authorities referred above transfer the information (DECLARE can be used for this as well) to the 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.

Regulation (EU) No 511/2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the 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); National Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014; National Strategy on Biological Diversity, § 34 a National Patent Act

There is no specific legislation on access to genetic resources as well as benefit-sharing in Germany. Accordingly, there are no requirements to obtain PIC and MAT when accessing genetic resources in Germany. However legislation on nature and species conservation, private property et.al. may apply depending on circumstances (i.e. a collection permit by the local nature conservation authority may be necessary due to species conservation). Germany provides access to Plant Genetic Resources for Food and Agriculture under the Standard Material Transfer Agreement (SMTA) of the International Treaty on Plant Genetic Resources for Food and Agriculture.

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.

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

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

Regulation (EU) No 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) No 511/2014 as regards register of collections, monitoring user compliance and best practices; entered into force on 9 November 2015; - in Germany, the EU legislation is supplemented by the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014 which entered into force on 1 July 2016. According to Article 9 of the EU ABS Regulation the CNA is obliged to perform checks on user compliance in accordance with periodically reviewed risk-based plans or upon substantiated concerns

Germany has taken action in several instances of non-compliance where users were initially unable to provide PIC and MAT from the provider country. In two cases, fines were imposed. In the remaining cases, the users were able to submit the required documentation retrospectively.

In the course of a checkpoint communiqué, the German CNA was informed by a Party, that the documents submitted were not valid ABS documents. The situation was resolved by requiring the user to apply for the necessary documentation, after which the documents were successfully issued in the provider country. In some cases identified during user checks, the German CNA contacted the provider countries to clarify whether their national ABS measures applied to the specific situation and received constructive feedback. In other cases, however, the NFPs did not respond to the requests. As a result, the legal situation remained unclear and, although a violation of national ABS measures may have occurred, the proceedings had to be discontinued.

Regulation (EU) No 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) No 511/2014 as regards register of collections, monitoring user compliance and best practices; entered into force on 9 November 2015; - in Germany, the EU legislation is supplemented by the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014 which entered into force on 1 July 2016. According to Article 9 of the EU ABS Regulation the CNA is obliged to perform checks on user compliance in accordance with periodically reviewed risk-based plans or upon substantiated concerns

The compliance checks conducted by the CNA did not reveal any such issues

The compliance checks conducted by the CNA did not reveal any such issues

There are two checkpoints in Germany, as established at EU level in Article 7 of EU Regulation Nr. 511/2014: 1st checkpoint: competent authorities designated under Regulation (EU) No 511/2014, i.e. the Federal Agency for Nature Conservation 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 No 511/2014, i.e. the Federal Agency for Nature Conservation 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 the submission of both checkpoints, the online tool DECLARE by the EU Commission can be used; authorities referred above transfer the information (DECLARE can be used for this as well) to the 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.

No publication on the ABS Clearing-House in cases of confidential information. In such cases the provider countries may be addressed directly.

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Article 13 of Regulation (EU) No 511/2014 obliges the European 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. For the gathering of due diligence declarations and their conversion into checkpoint communiqués an IT tool called "DECLARE" has been developed by the European Commission and is used by the Federal Agency for Nature Conservation as the German checkpoint. DECLARE is connected with the ABS CH to transform Due Diligence Declarations into CPC via API.In addition, information exchange during compliance checks with the users concerned is conducted by email, except in the case of on-site inspections.

Not applicable, since no access requirements are in place

Recourse can be sought subject to the rules of international civil procedure applicable in Germany (see, in particular, Regulation (EU) No 1215/2012 of the European Parliament and of The Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (recast) regarding international jurisdiction).

Cf. answer to Question 26

- Recognition and Enforcement of foreign judgments in private contractual matters given by courts of other Member States of the European Union are generally governed by Regulation (EU) No 1215/2012 of the European Parliament and of The Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (recast). In addition, international conventions as well as national rules in the German Code of Civil Procedure provide for recognition and enforcement of foreign judgments, based on reciprocity and subject to a limited number of grounds for refusal. - Recognition and Enforcement of foreign arbitral awards is governed by the New York Convention of 10 June 1958 on the Recognition and Enforcement of Foreign Arbitral Awards.

As Germany has not introduced specific legislation regulating access to its in situ genetic resources, no obstacles are created and research is facilitated.

Article 4(8) of Regulation (EU) No 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.

Not applicable, as Germany has not introduced specific legislation regulating access.

Germany implements Article 8c by supporting the implementation of the ITPGRFA and its Multilateral System. Germany facilitates access to plant genetic resources for food and agriculture by providing them via SMTA of the ITPGRFA. Germany has not introduced access legislation for genetic resources for food and agriculture and facilitates international cooperation regarding conservation and sustainable use of GRFA. Recital 12 of Regulation (EU) No 511/2014 recalls Article 8(c) of the Nagoya Protocol and explains that the ITPGRFA is a specialised instrument within the meaning of Article 4(4) of the Protocol. The EU ABS 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.

Germany has not introduced specific legislation regulating access.

In line with Article 13 of Regulation (EU) No 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 Germany has not introduced specific legislation regulating access.

Not applicable, since no access requirements are in place

Not applicable, since no access requirements are in place

In line with Article 13 of Regulation (EU) No 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. The German Research Foundation (Deutsche Forschungsgemeinschaft - DFG) has developed model contractual clauses for researchers applying for DFG funding.

- Under Article 8 of the Regulation (EU) No 511/2014 associations of users or other interested parties may apply to the Commission for the recognition of procedures, tools or mechanisms developed and overseen by them as a best practice in accordance with this Regulation. The use of such recognised procedures may be taken into account as a mitigating factor when selecting potential users for risk-based controls. Currently there is one best practice recognized through a Commission decision (by the Consortium of European Taxonomic Facilities - CETAF), - In line with Article 13 of the Regulation (EU) No 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. The German Research Foundation (Deutsche Forschungsgemeinschaft - DFG) has developed ABS guidelines for researchers applying for DFG funding as well as ABS Guidelines for universities and other research institutions regarding compliance measures.

In view of its obligations under Article 21 of the NP, Germany has continuosly undertaken a series of different awareness-raising activities including amongst others: - Updating and further development of national ABS clearing-house, - Series of workshops and seminars to inform different user sectors, - Helpdesk for all users and collections in Germany, - Funding for the establishment and the first three years of the “Nagoya-Protocol- Hub”, that provides guidance, information, and networking for academic researchers navigating legal obligations regarding the Nagoya Protocol (https://nagoyaprotocol-hub.de/), - regular round tables for research, industry and politics

Internal strategy only

- Germany, together with other EU member States, has actively supported the EU Commission in developing the EU Guidance on the Regulation (EU) No 511/2014 on the compliance measures for users from the Nagoya Protocol in the Union, - Germany has funded different projects such as establishing the "Nagoya Protocol Hub" for academic researchers (cf. question 53) or the project "ABS - Cooperation on Eye-level". - - - Germany, through its Federal Agency for Nature Conservation, has conducted three meetings of EU competent national authorities to support the implementation of the EU ABS legislation as well as the Nagoya Protocol. These EU CNA meetings serve to facilitate the exchange of experiences and to promote a harmonised approach to the implementation of the EU Regulations; - in addition, workshops and meetings with different user sectors were funded to strengthen their capacities and enhance their understanding of the regulatory frameworks within which they operate.

- Germany has supported the Informal Advisory Committee on CB by sending a national expert, - Germany has funded workshops with provider countries to understand better national ABS procedures in 2017 and 2018 - Germany has financially supported the two ABS Global Workshops of the CBD Secretariat in Bonn in 2019 und 2024 - Through its Federal Ministry of Economic Cooperation and Development (Bundesministerium für wirtschaftliche Zusammenarbeit und Entwicklung, BMZ) as well as the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH, Germany is supporting different ABS capacity-building efforts in accordance with Article 22 of the NP and the strategic framework/ action plan for capacity-building, such as the international ABS Capacity Development Initiative which was founded by BMZ and was managed by GIZ.

E.g. - funding of projects (e.g. ET-NMBS (examining trends for non-monetary benefit sharing), FAR-DSI (feasibility of a regulation for digital sequence information), ABS cooperation on Eyelevel) - contribution to scientific publications through articles (e.g. in Global Transformations in the Use of Biodiversity for Research and Development, E. Kamau, 2022) - ABS Dialogues with provider countries on the island of Vilm in 2017 and 2018 - Special Edition of "Natur und Landschaft" on 10 Years of the Nagoya-Protocol in 2024 - Trainings for different user sectors (e.g. cosmetics, biotechnology, pharmacy

The German Federal Ministry for Economic Cooperation and Development (BMZ) is furthering the implementation of the Nagoya Protocol, financially, through its contribution to the Global Environmental Facility (GEF). It has also financially supported the ABS Capacity Development Initiative.

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The positions responsible for the implementation of the Nagoya Protocol are funded through the federal budget. No mechanism for generating additional funds is in place

Staff is employed on permanent contracts

ITPGRFA, WHO- PIP framework, BBNJ in progress, involved in the ongoing negotiations on the WHO PABS

The national acts to ratify and implement BBNJ are currently going through the parliamentary legislative process