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 NAGOYA PROTOCOLNAGOYA PROTOCOLon Access to Genetic Resources and the Fair and Equitable Sharing

of Benefits Arising from their Utilization to the Convention on

Biological Diversity

ACCESS AND BENEFIT-SHARING (ABS)

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GENETIC RESOURCES, ABS AND NAGOYA

ABS can be an Anti-Lock Braking System in cars that saves lives. Nagoya is a city in Japan. So what does that have to do with genetic resources and biodiversity?

Preserving and researching biodiversity is extremely important, and not just for ecological reasons. The use of genetic resources (and biodiversity in general) has considerable economic and social value, because they serve as the basis for the development of products and applications for a variety of industries, including health, agriculture and horticulture, cosmetics and healthcare, biotechnology, etc.

ABS stands for “access and benefit-sharing”, meaning access to genetic resources and the fair and equitable sharing of benefits that are derived from their utilisation. ABS – a concept which is anchored in the Convention on Biological Diversity (CBD) and further elaborated in the Nagoya Protocol – aims to create economic incentives for the conservation and sustainable use of biodiversity through its valorisation. In this context, it is not only the potential for the use of genetic resources that is considered, but also the use of so-called traditional knowledge relating to genetic resources.

ABS also takes into account the fact that every Party to the CBD and Nagoya Protocol is a sovereign state. A country is therefore fully entitled to decide whether to provide free access to its genetic resources or the traditional knowledge relating to them, or whether to grant access only after giving its Prior Informed Consent (PIC) and regulating the distribution of benefits arising from their utilisation based on Mutually Agreed Terms (MAT).

The Nagoya Protocol entered into force on 12 October 2014.

The Nagoya Protocol entered into force on 12 October 2014.

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Genetic ResourceGenetic ResourceA genetic resource is any material of plant, animal, microbial or other origin that contains genetic information. This therefore covers all biological organisms from an amoeba to an elephant, from a virus to an orchid.

A genetic resource is any material of plant, animal, microbial or other origin that contains genetic information. This therefore covers all biological organisms from an amoeba to an elephant, from a virus to an orchid.

ABSABSABS stands for “access and benefit-sharing”. It is the technical term for access to genetic resources and the fair and equitable sharing of benefits, the third objective of the CBD.

ABS stands for “access and benefit-sharing”. It is the technical term for access to genetic resources and the fair and equitable sharing of benefits, the third objective of the CBD.

CBDCBDCBD is the abbreviation for the “Convention on Biological Diversity”. The CBD entered into force on 29 December 1993 and has the following three aims, each of equal importance:

CBD is the abbreviation for the “Convention on Biological Diversity”. The CBD entered into force on 29 December 1993 and has the following three aims, each of equal importance:

• • the conservation of biodiversity,the conservation of biodiversity,• • the sustainable use of its components, andthe sustainable use of its components, and• • the fair and equitable sharing of benefits arising

from the utilisation of genetic resources.the fair and equitable sharing of benefits arising from the utilisation of genetic resources.

More information can be found at: More information can be found at: www.cbd.int/www.cbd.int/

Nagoya ProtocolNagoya ProtocolNagoya Protocol is the short version of the title of an international agreement: “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity”. The Nagoya Protocol was adopted on 29 October 2010 at the tenth Conference of the Parties to the CBD in the city of Nagoya, Japan. Its aim is to further substantiate the CBD’s ABS obligations. The Nagoya Protocol entered into force on 12 October 2014.

Nagoya Protocol is the short version of the title of an international agreement: “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity”. The Nagoya Protocol was adopted on 29 October 2010 at the tenth Conference of the Parties to the CBD in the city of Nagoya, Japan. Its aim is to further substantiate the CBD’s ABS obligations. The Nagoya Protocol entered into force on 12 October 2014.

More information can be found at: More information can be found at: www.cbd.int/abs/www.cbd.int/abs/

Traditional KnowledgeTraditional KnowledgeThe so-called “Traditional Knowledge” (TK) of indigenous and local communities can contain interesting leads to various uses of biological resources, and these are often consulted as part of research work.

The so-called “Traditional Knowledge” (TK) of indigenous and local communities can contain interesting leads to various uses of biological resources, and these are often consulted as part of research work.

Utilisation of Genetic ResourcesUtilisation of Genetic ResourcesUtilisation means carrying out research and/or development work on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. It does not matter whether such work is carried out for commercial or non-commercial purposes.

Utilisation means carrying out research and/or development work on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. It does not matter whether such work is carried out for commercial or non-commercial purposes.

AccessAccessAccess to genetic resources refers to the physical acquisition of such resources in a country. To answer the question of when and where the resources are accessed, the key factors are the time and place in which the resources are collected in-situ, or acquired via an ex-situ collection or a trader in a provider country.

Access to genetic resources refers to the physical acquisition of such resources in a country. To answer the question of when and where the resources are accessed, the key factors are the time and place in which the resources are collected in-situ, or acquired via an ex-situ collection or a trader in a provider country.

Provider CountryProvider CountryThe provider country is the country of origin of a genetic resource, or a country that has acquired a genetic resource in accordance with the CBD.

The provider country is the country of origin of a genetic resource, or a country that has acquired a genetic resource in accordance with the CBD.

PICPIC“Prior Informed Consent” is the technical term for the approval which every country that is a Party to the Nagoya Protocol can require before granting access to its genetic resources.

“Prior Informed Consent” is the technical term for the approval which every country that is a Party to the Nagoya Protocol can require before granting access to its genetic resources.

MATMAT“Mutually Agreed Terms” is the technical term for contractual arrangements which form the legal basis for the fair and equitable sharing of benefits arising from the utilisation of genetic resources.

“Mutually Agreed Terms” is the technical term for contractual arrangements which form the legal basis for the fair and equitable sharing of benefits arising from the utilisation of genetic resources.

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NEW DEVELOPMENTS INITIATED BY THE NAGOYA PROTOCOL

The new features of the Nagoya Protocol, i.e. the advancements of the ABS principles of the CBD, can be described as the so-called ABC of ABS:

AccessThe Protocol introduces international “standards” or criteria for national access measures. Countries that are Party to the Nagoya Protocol who wish to regulate access to their genetic resources and associated traditional knowledge are now obliged to make these rules clear and transparent.

Benefit-SharingThe Protocol also strengthens the rights of indigenous and local communities with regards to the potential sharing of benefits, whereby their rights shall be taken into greater consideration when negotiating benefit-sharing.

ComplianceIn order to avoid future cases of biopiracy, all countries that are Party to the Nagoya Protocol must provide that only legally acquired genetic resources are used within their country’s territory and that the benefits that are generated are shared with the provider country. They are therefore obliged to carry out checks and punish any violations to this rule.

ABS Clearing-HouseThe “Access and Benefit-Sharing Clearing-House” (ABS CH) is a website that has been set up by the CBD Secretariat, which aims to support the implementation of the Nagoya Protocol. Amongst others, it provides the following information: List of countries that are Party to the Nagoya Protocol, National Focal Points for ABS and Competent National Authorities, as well as reported national legislative, administrative or policy measures on ABS.

More information can be found at: https://absch.cbd.int/

ABS Clearing-HouseThe “Access and Benefit-Sharing Clearing-House” (ABS CH) is a website that has been set up by the CBD Secretariat, which aims to support the implementation of the Nagoya Protocol. Amongst others, it provides the following information: List of countries that are Party to the Nagoya Protocol, National Focal Points for ABS and Competent National Authorities, as well as reported national legislative, administrative or policy measures on ABS.

More information can be found at: https://absch.cbd.int/

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OTHER INTERNATIONAL ABS INSTRUMENTS

The rules for accessing genetic resources and the fair and equitable sharing of benefits arising from their utilisation are based on various legal instruments:

CBD and the Nagoya Protocol are the key pillars of the international ABS regime.

In addition, there are the Bonn Guidelines which were adopted in April 2002 at the sixth Conference of the Parties to the CBD. The Bonn Guidelines contain voluntary legislative, administrative or policy measures regarding access and benefit-sharing.

More information can be found at: www.cbd.int/abs/

There are also other complementary ABS instruments for various sectors. However, a prerequisite for their application is that they are supportive of and do not run counter to the objectives of the CBD and the Nagoya Protocol. The instrument that may apply when accessing and utilising genetic resources for food and agriculture is the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) of the UN Food and Agriculture Organisation (FAO).

More information can be found at:

www.planttreaty.org

In case of human pathogens, the Pandemic Influenza Preparedness Framework (PIPF) of the World Health Organisation (WHO) may contain relevant access and benefit-sharing rules.

More information can be found at: www.who.int/influenza/pip/en

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IMPLEMENTING THE NAGOYA PROTOCOL WITHIN THE EU

The Nagoya Protocol is implemented within the European Union through:

Regulation (EU) No 511/2014 – hereinafter the “Basic Regulation”The formal title of the Basic Regulation is “Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 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 Utilization in the Union”.

Regulation (EU) 2015/1866 – hereinafter the “Implementing Regulation”The formal title of the Implementing Regulation is “Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices”.

A(ccess)A(ccess)

Rules set by each respective EU Member State

B(enefit-shAring)B(enefit-shAring)

Rules set by each respective EU Member State

c(ompliAnce)c(ompliAnce)

Harmonized rules at the EU level

NoteNoteThe EU legislation “only” includes so-called compliance measures. These measures aim to ensure that access to genetic resources (or associated traditional knowledge) in another country that is Party to the Nagoya Protocol takes place in accordance with its applicable ABS rules, and that any potential benefits that arise from the utilisation of the resources (or traditional knowledge) are shared fairly and equitably with this Party.

The EU legislation “only” includes so-called compliance measures. These measures aim to ensure that access to genetic resources (or associated traditional knowledge) in another country that is Party to the Nagoya Protocol takes place in accordance with its applicable ABS rules, and that any potential benefits that arise from the utilisation of the resources (or traditional knowledge) are shared fairly and equitably with this Party.

However, it is left entirely up to the EU Member States themselves to decide whether and how they regulate access to their genetic resources and traditional knowledge, as well as the sharing of any benefits that may arise from their utilisation.

However, it is left entirely up to the EU Member States themselves to decide whether and how they regulate access to their genetic resources and traditional knowledge, as well as the sharing of any benefits that may arise from their utilisation.

More information can be found at: More information can be found at: http://ec.europa.eu/environment/nature/biodiversity/international/abs/index_en.htmhttp://ec.europa.eu/environment/nature/biodiversity/international/abs/index_en.htm

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SCOPE OF APPLICATION OF THE BASIC REGULATION

The scope of application of the Basic Regulation is limited in the following ways:

Material ScopeThe Basic Regulation applies only to genetic resources and traditional knowledge associated with them, excluding human genetic resources and genetic resources which are covered by specialized international ABS instruments applicable between Parties to such instruments.

Personal ScopeThe scope of application of the Basic Regulation includes both natural and legal persons, but only if they utilise the resources within the sense of the Basic Regulation in the EU (i.e. conducting research and/or development). Utilisation does not take place, if the resources are only stored, transferred, or used exclusively to trade, or if a product is put on the market without conducting research and/or development on the resources within the EU.

Geographical ScopeThe Basic Regulation only covers utilisation activities that take place within the EU. Furthermore, the genetic resources that are utilised must be subject to the sovereign rights of a country (i.e. they may not originate from the high seas, the deep sea bed or the Antarctic), they must have been accessed in a country that is Party to the Nagoya Protocol and this country must also regulate access to the genetic resources that are used.

Temporal ScopeFurthermore, the Basic Regulation only covers the utilisation of such genetic resources (or associated traditional knowledge) which are accessed as of 12 October 2014 (date of entry into force of the Nagoya Protocol and date of application of the Basic Regulation). If, however, the resources were accessed before this date, then the Basic Regulation does not apply, even if utilisation kicks in after 12 October 2014.

NoteNoteIf any one or more of the prerequisites outlined above are not met, then the Basic Regulation does not apply. However, this does not mean that the users are free from any obligations in every case. Existing ABS obligations of the provider country must still be upheld!

If any one or more of the prerequisites outlined above are not met, then the Basic Regulation does not apply. However, this does not mean that the users are free from any obligations in every case. Existing ABS obligations of the provider country must still be upheld!

Example: The Basic Regulation is not applicable if a provider country has not yet become a Party to the Nagoya Protocol. However, any ABS rules that already exist in the country must be adhered to, even if it will not be subjected to checks as part of the EU regulations.

Example: The Basic Regulation is not applicable if a provider country has not yet become a Party to the Nagoya Protocol. However, any ABS rules that already exist in the country must be adhered to, even if it will not be subjected to checks as part of the EU regulations.

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DUE DILIGENCE OBLIGATION

The core of the EU ABS rules is the so-called due diligence obligation. According to this, all users of genetic resources (and of associated traditional knowledge) are obliged to act with the necessary level of care to determine whether their utilisation is legal. This is the case if access to the resources (or traditional knowledge) took place in accordance with the relevant legal or other requirements of the provider country, and if the benefits, where applicable, are shared in a fair and equitable manner. The purpose of due diligence is generally to avoid unnecessary risks in business relationships and establish legal liability for negligence.

The rules establishing the due diligence obligation provide for a duty of users to carry out risk management, which is based on three main elements:

Documentation ObligationDocumentation Obligation

According to the Basic Regulation, documents must be:

• obtained,

• kept (for 20 years after utilisation has ended),

• transferred to third parties.

Risk Assessment Obligation

Risk Assessment Obligation

In the event of insufficient information or uncertainties about the legality of access and utilisation:

• PIC and MAT or equivalent documents must be obtained retrospectively, or

• utilisation must be discontinued.

Options for Mitigating Risks

Options for Mitigating Risks

• Acquiring genetic resourcesfrom registered collections as foreseen in the Basic Regulation,

• Using best practices recognized in accordance with the Basic Regulation or the Nagoya Protocol.

Due DiligenceDue DiligenceDue diligence obligations by users are a political instrument that is also used in other areas of EU environmental legislation (see e.g. due diligence as part of the EU Timber Regulation, Regulation (EU) No 995/2010 of 20 October 2010). The establishment of the due diligence obligation according to Article 4 of the Basic Regulation takes into account that genetic resources are used in different ways in research and development projects. The various users (or user sectors) are therefore particularly suitable – either individually or through their associations – for developing appropriate processes and standards to exercise due diligence.

Due diligence obligations by users are a political instrument that is also used in other areas of EU environmental legislation (see e.g. due diligence as part of the EU Timber Regulation, Regulation (EU) No 995/2010 of 20 October 2010). The establishment of the due diligence obligation according to Article 4 of the Basic Regulation takes into account that genetic resources are used in different ways in research and development projects. The various users (or user sectors) are therefore particularly suitable – either individually or through their associations – for developing appropriate processes and standards to exercise due diligence.

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DUE DILIGENCE DECLARATIONS

In addition to exercising due diligence, the Basic Regulation also stipulates that users of genetic resources (or associated traditional knowledge) are obliged to make so-called due diligence declarations at two stages of the research and development chain:

Research FundingIn the phase of research funding, whether from public or private sources, a declaration is to be made at the earliest after the first funding rate has been received and all of the genetic resources have been acquired, but at the latest at the end of the project.

Product DevelopmentIn the final phase of a product’s development, a declaration has to be made e.g. before market approval or authorisation is sought, or before it is placed on the market for the first time.

The content of the declaration, which has to be made to the competent national authority, is drawn from the Implementing Regulation. Due diligence declarations should be submitted through the online system DECLARE.

The competent national authority transmits the information that is collected to the ABS Clearing-House, the European Commission and, if applicable, the responsible national authorities of the provider country, taking due account of the respect of confidentiality of commercial or industrial information.

NoteNoteRegardless of whether there is an obligation to make a due diligence declaration or not, there is still a general obligation to exercise due diligence throughout the entire value chain. The competent national authorities check that these obligations are upheld.

Regardless of whether there is an obligation to make a due diligence declaration or not, there is still a general obligation to exercise due diligence throughout the entire value chain. The competent national authorities check that these obligations are upheld.

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REGISTER OF COLLECTIONS

Collections are important suppliers of genetic resources that are used in Germany. The Basic Regulation foresees a register of recognised collections within the European Union which aims to support users in fulfilling their due diligence obligations.

The register is a voluntary, internet-based tool within the EU which contains the information outlined in the Implementing Regulation (e.g. registration code, name, contact details, short description) for every recognised collection or every part of a recognised collection.

For users who obtain genetic resources from a collection listed in the register, it is assumed that they have exercised due diligence as regards the seeking of the necessary information.

In order to be included in the EU register of collections, a collection holder must make an application to the competent national authority and prove that the prerequisites outlined in the Basic Regulation are fulfilled. These include, for example, the application of standardised procedures for exchanging samples and supplying them in accordance with the Nagoya Protocol. After a collection is registered, the Member State in which the collection is located regularly verifies that the prerequisites are still met.

The content of the registration application can be drawn from the Implementing Regulation.

CollectionCollectionA “collection” refers to a set of samples of genetic resources and associated information that have been gathered and stored. Collections can be both publicly and privately owned.

A “collection” refers to a set of samples of genetic resources and associated information that have been gathered and stored. Collections can be both publicly and privately owned.

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BEST PRACTICES

Best practices which, upon application, have been recognised by the European Commission in accordance with the Basic Regulation, or by the international community in accordance with the Nagoya Protocol, play an important role in exercising due diligence. A combination of procedures, tools or mechanisms should enable various users to establish a system for exercising due diligence at an affordable cost and with a high level of legal certainty. In the past, such best practices have already been applied particularly in non-commercial research sectors.

The application for recognition of a best practice has to be made to the European Commission by user associations or interested stakeholders. The content of the application can be drawn from the Implementing Regulation.

The Commission is to be informed of any changes or updates made to a recognised best practice. In the event of repeated or significant cases where users implementing a best practice have failed to comply with their due diligence obligations, the European Commission examines whether these cases of non-compliance are due to deficiencies in the best practice; if necessary, recognition of a best practice can be withdrawn.

Example of a possible best practiceExample of a possible best practiceAlready in 2001, the International Plant Exchange Network (IPEN) was founded to allow participating botanical gardens a facilitated exchange of plant material. The basic principles of the IPEN, which can form the basis for best practices for collections, include in particular:

Already in 2001, the International Plant Exchange Network (IPEN) was founded to allow participating botanical gardens a facilitated exchange of plant material. The basic principles of the IPEN, which can form the basis for best practices for collections, include in particular:

• • Accepting only plant material that has been legally acquired in accordance with CBD provisions;Accepting only plant material that has been legally acquired in accordance with CBD provisions;• • Using and exchanging material within the IPEN only with the permission of the provider country, and only

for non-commercial purposes in the fields of research, education and conservation;Using and exchanging material within the IPEN only with the permission of the provider country, and only for non-commercial purposes in the fields of research, education and conservation;

• • Obtaining a new PIC from the provider country for uses not covered by the terms under which the material was originally acquired;Obtaining a new PIC from the provider country for uses not covered by the terms under which the material was originally acquired;

• • Transferring material to third parties (outside of IPEN) under the same terms under which it was acquired from the provider country, and only if the necessary information is also passed on to the third party and the latter is obliged to act in compliance with ABS;

Transferring material to third parties (outside of IPEN) under the same terms under which it was acquired from the provider country, and only if the necessary information is also passed on to the third party and the latter is obliged to act in compliance with ABS;

• • Transferring material to third parties for commercial purposes only if the recipient has a PIC from the provider country;Transferring material to third parties for commercial purposes only if the recipient has a PIC from the provider country;

• • Documenting the origin of the material and any limitations in terms of use and transfer by means of an IPEN number;Documenting the origin of the material and any limitations in terms of use and transfer by means of an IPEN number;

• • Sharing benefits with the provider country, particularly in the event of benefits arising from non-commercial utilisation.Sharing benefits with the provider country, particularly in the event of benefits arising from non-commercial utilisation.

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ABS IN GERMANY

The regulations at EU level (Basic and Implementing Regulations) concern measures that aim to ensure that genetic resources (or traditional knowledge associated with them) are accessed in accordance with the applicable ABS rules of the provider country, and that any benefits which may arise are shared fairly and equitably.

The EU legislation is implemented in Germany through the Act Implementing the Obligations under the Nagoya Protocol and Transposing Regulation (EU) No 511/2014. The Implementing Act entered into force on 1 July 2016. It outlines institutional competencies, establishes enforcement powers and determines possible sanctions for violations.

EU Member States are free to decide whether they wish to regulate access to genetic resources (or associated traditional knowledge) within their jurisdiction or grant free access.

Access to genetic resources in Germany is not tied to any special ABS obligations. This means collecting genetic resources native to Germany in-situ, as well as acquiring such resources via an ex-situ collection located in Germany, does not require any ABS permit (PIC) or any ABS agreement (MAT).

More information can be found at: http://abs.bfn.de

NoteNoteCollecting genetic resources in Germany is only subject to the general limitations of public law and private law (e.g. Federal Nature Conservation Act, nature conservation acts and forestry acts of the federal states (Bundesländer), Seed Marketing Act, etc.). Ex-situ access to genetic resources via a collection located in Germany can, however, potentially be tied to ABS rights of the provider country in which the resources were originally collected in-situ.

Collecting genetic resources in Germany is only subject to the general limitations of public law and private law (e.g. Federal Nature Conservation Act, nature conservation acts and forestry acts of the federal states (Bundesländer), Seed Marketing Act, etc.). Ex-situ access to genetic resources via a collection located in Germany can, however, potentially be tied to ABS rights of the provider country in which the resources were originally collected in-situ.

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RESPONSIBILITIES

The Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (Bundesministerium für Umwelt, Naturschutz, Bau und Reaktorsicherheit – BMUB), is the National Focal Point for the Nagoya Protocol in Germany. It is responsible for international reporting on the Nagoya Protocol.

The national authority that is responsible for the implementation and enforcement of the Nagoya Protocol in Germany (Competent National Authority) is the Federal Agency for Nature Conservation (Bundesamt für Naturschutz – BfN).

Federal Agency for Nature Conservation (BfN)Division 1.4ICompetent National Authority for the Nagoya ProtocolKonstantinstr. 110D-53179 BonnTel: +49 (0) 228 8491-1311Fax: +49 (0) 228 8491-1319E-Mail: Nagoya-CNA@bfn.deWeb: http://abs.bfn.de

In its work as Competent National Authority, the BfN collaborates closely with the Federal Office for Agriculture and Food (Bundesanstalt für Landwirtschaft und Ernährung – BLE) for matters relating to genetic resources for food and agriculture, and with the Robert Koch Institute (RKI) for matters relating to human pathogens based on administrative agreements. Furthermore, the BfN cooperates with the German Patent and Trademark Office (Deutsches Patent und Markenamt – DPMA). The DPMA informs the BfN where an invention is based on biological material of plant or animal origin or if it uses such material, and if the application includes information on the geographical origin of such material.

As the Competent National Authority for the Nagoya Protocol, the BfN undertakes, among others, the following tasks:

• Receiving due diligence declarations from users,• Receiving and verifying applications for the registration of collections and regularly checking that the prereq

uisites for registration are met,• Checking user compliance on the basis of substantiated concerns and/or risk-based plans,• Intervening and, if necessary, sanctioning in the event users violate their obligations to exercise due diligence,

make due diligence declarations and cooperate,• Cooperating with responsible authorities in provider countries, and• Serving as point of contact and helpdesk for all users and collections in Germany.

As the Competent National Authority for the Nagoya Protocol, the BfN undertakes, among others, the following tasks:

• Receiving due diligence declarations from users,• Receiving and verifying applications for the registration of collections and regularly checking that the prereq

uisites for registration are met,• Checking user compliance on the basis of substantiated concerns and/or risk-based plans,• Intervening and, if necessary, sanctioning in the event users violate their obligations to exercise due diligence,

make due diligence declarations and cooperate,• Cooperating with responsible authorities in provider countries, and• Serving as point of contact and helpdesk for all users and collections in Germany.

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RECOMMENDATIONS FOR ACTION

Step When collecting genetic resources for the purpose of utilisation

When obtaining genetic resources from third parties for the purpose of utilisation

Step When collecting genetic resources for the purpose of utilisation

When obtaining genetic resources from third parties for the purpose of utilisation

1.Check whether the requirements for application of Regulation (EU) No 511/2014 and hence the German Implementing Act are fully met.

2.Check whether it is possible in your institution to implement a best practice for which recognition has already been granted.

3.Before collecting/acquiring/utilising genetic resources, inform yourself about the legal framework and the competent authorities in the provider country.

4.Contact the competent national authorities with regard to access procedures, benefit-sharing rules, use restrictions, competencies, etc.

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5.

Apply for/negotiate any ABS documents needed, stating the intended utilisation of the resources (e.g. commercial/non-commercial research, transfer to third parties, publishing research data). Note: Different permits from different authorities may be necessary. Cooperation with local partners in provider countries may facilitate ABS processes.

Demand the necessary ABS documents and related information from the third party (trader/collection) providing the genetic resources.

6. Keep records of your proceedings in order to demonstrate that due diligence has been exercised.

7.When receiving external research funding from private or public sources, submit a due diligence declaration to the BfN on time.

8.In the case of a patent application, disclose the geographical origin of the genetic resource underlying the invention.

9. When developing a product, submit a due diligence declaration to the BfN on time.

10.Ensure that the utilisation of the genetic resources is in line with the obligations and benefit-sharing arrangements stipulated in the ABS permits and contracts.

11.In case of uncertainty about the legality of access and the utilisation of genetic resources, seek the necessary ABS documents retrospectively or discontinue the utilisation.

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PUBLICATION DETAILSPUBLICATION DETAILSAuthors: Ramona Stiegeler, Thomas Greiber, Ellen Frederichs, Ute

FeitAuthors: Ramona Stiegeler, Thomas Greiber, Ellen Frederichs, Ute

Feit

Publisher: Federal Agency for Nature Conservation (BfN)Publisher: Federal Agency for Nature Conservation (BfN)Division 1.4I

Competent National Authority for the Nagoya ProtocolKonstantinstr. 110D-53179 BonnTel: +49 (0) 228 8491-1311Fax: +49 (0) 228 8491-1319E-Mail: Nagoya-CNA@bfn.deWeb: http://abs.bfn.de

Division 1.4Competent National Authority for the Nagoya ProtocolKonstantinstr. 110D-53179 BonnTel: +49 (0) 228 8491-1311Fax: +49 (0) 228 8491-1319E-Mail: Nagoya-CNA@bfn.deWeb: http://abs.bfn.de

The publisher takes no guarantee for correctness, details and completeness of statements and views in this publication as well as no guarantee for respecting private rights of third parties. Views expressed in this publication are those of the authors and do not necessarily represent those of the publisher.

The publisher takes no guarantee for correctness, details and completeness of statements and views in this publication as well as no guarantee for respecting private rights of third parties. Views expressed in this publication are those of the authors and do not necessarily represent those of the publisher.

This publication is copyright protected. No part of the material protected by this copyright notice may be reproduced or utilised in any form or by any means without written permission from the copyright owner.

This publication is copyright protected. No part of the material protected by this copyright notice may be reproduced or utilised in any form or by any means without written permission from the copyright owner.

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Cover: istockphoto.com/cherezoffImage credits: p. 2 ©istockphoto.com/spawns; p. 4 ©istockphoto.com/Utopia_88; p.6 ©istockphoto.com/HYWARDS; p. 8 ©istockphoto.com/wildpixel; p. 10 ©istockphoto.com/Сергей Хакимуллин; p. 12 ©istockphoto.com/dra_schwartz; p. 14 Artsiom; p.16 ©istockphoto.com/ktsimage; p. 18 ©istockphoto.com/Yuri_Arcurs ; p. 20 ©istockphoto.com/Nikada; p. 22 ©istockphoto.com/Valentina_G; p. 24, ©istockphoto.com/DanComaniclu; p. 18 p. 26 ©istockphoto.com/Leonardo Patrizi

Cover: istockphoto.com/cherezoffImage credits: p. 2 ©istockphoto.com/spawns; p. 4 ©istockphoto.com/Utopia_88; p.6 ©istockphoto.com/HYWARDS; p. 8 ©istockphoto.com/wildpixel; p. 10 ©istockphoto.com/Сергей Хакимуллин; p. 12 ©istockphoto.com/dra_schwartz; p. 14 Artsiom; p.16 ©istockphoto.com/ktsimage; p. 18 ©istockphoto.com/Yuri_Arcurs ; p. 20 ©istockphoto.com/Nikada; p. 22 ©istockphoto.com/Valentina_G; p. 24, ©istockphoto.com/DanComaniclu; p. 18 p. 26 ©istockphoto.com/Leonardo Patrizi

Translation by: inlingua Language Center BonnTranslation by: inlingua Language Center Bonn

Bonn-Bad Godesberg, November 2016, 1st editionBonn-Bad Godesberg, November 2016, 1st edition

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