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Research Organisation

Compliance stories

Learning from experience: Research organisation

 

Type of institution: A non-profit organization made up of different research institutes

Networking: This organization has created an internal network to promote Nagoya Protocol compliance. There are several aspects to the network:

  • coordination

 

  • contact person at each institute

 

  • information sessions and awareness-raising

 

  • making resources and information available

 

Photo: Chokniti Khongchum from Pexels

Coordination

The internal network is coordinated centrally by a person from the legal department (head office).

The coordinator:

  • organizes the internal network meetings
  • organizes external information sessions
  • answers questions about ABS and compliance
  • administers the internal platform on the organization’s intranet
  • in responsible for disseminating information internally (to all of the institutes as well as the management levels of the organization)
  • participates in external meetings organized by the German Nagoya Protocol Hub, BfN and others
  • elaborates information materials, such as model procedures, checklists, guidelines and best practices as well as model clauses in coordination with others units of the head office
  • updates the organization´s internal manual regarding compliance

Nomination of contact persons

Within the organization, there are around 30 institutions where Nagoya Protocol relevant research may potentially take place. The head office sent a letter to  each of these institutes asking them to nominate a Nagoya Protocol contact person (it was not mandatory).

The contact person is asked to:

  • participate in internal network meetings where progress, activities, challenges etc. are discussed
  • disseminate information provided by the head office to relevant persons within their institute
  • serve as first point of contact for questions at their own institute and a link to the coordinator at the head office
  • exchange information and ideas on the internal platform of the organizations intranet
  • serve as a contact person for external inquiries, for example from the competent authority
  • may be asked to file the institute’s due diligence declarations through the DECLARE system

Some of the institutes have nominated more than one person. For example, at one institute this task is shared by four people. Each of the three potentially Nagoya Protocol relevant research areas has its own contact person and an additional person from the IT department is involved because the institution’s database will be modified to address compliance issues.

Information sessions and awareness-raising

In the first step, awareness-raising and information sessions are being targeted  at the Nagoya Protocol contact persons.

A series of information sessions are being organized for the contact persons, starting with the basics and then moving on to more complex issues and discussion of tools etc. that support ABS and compliance.

The Head Office organized these information sessions in cooperation with the German Nagoya Protocol HuB.

Internal resources and information

Internal resources are provided on the organisation’s intranet and the organisation’s internal manual has been updated with key information on compliance.

An internal platform on the organizations intranet has been established for the contact persons at each institute. This platform provides information and a place to exchange information and ideas.

The organizations internal manual has also been updated with key information on Regulation (EU) No 511/2014, including the scope of application and what is required to fulfill ones due diligence obligations.

There is still some work to do. The organization is planning to develop further instruments to support all researchers in the organization, including:

  • information materials and tools, such as model procedures, checklists, guidelines and best practice
  • an addenda (model clauses) for cooperation agreements and material transfer agreements which address compliance issues

What are the lessons learned?

Internal networking facilitates the exchange of information, helps to identify the problems and needs of researchers. This allows support to be more targeted

For the internal network to function, it is key that one person takes on the coordination role.

When raising-awareness, it is important to communicate that due diligence obligations apply to all users of genetic resources falling in the scope of Regulation (EU) No 511/2014 regardless of the intended use (commercial or non-commercial research, basic and applied research or product development).

Although there are contact persons at the institutes and in the legal department of the head office who can provide some support, individual scientists must understand that they are personally responsible for obtaining the necessary ABS-documents and fulfilling the due diligence obligations.

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Registered collection

 

The German Nagoya Protocol HuB is financed by the Federal Agency for Nature Conservation (Bundesamt für Naturschutz) with funds from the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection (Bundesministerium für Umwelt, Naturschutz, nukleare Sicherheit und Verbraucherschutz)

 

 

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  • Some countries also have ABS laws even though they are NOT Party to the Nagoya Protocol. You still must comply with these laws!
  • Some countries in the EU also have specific national ABS laws.
  • If your research will involve traditional knowledge, you must take into account the national ABS rules in this regard.

In cases of non-compliance the National Authority (BfN) can:

  • confiscate the material.
  • prohibit further use and transfer of the material for research.
  • prohibit the publication or sharing of any results of utilization.
  • issue a fine of up to 50,000 EUR.

Check out more about the implications of non-compliance.

How do I check?

  • Start with the country profile in the ABS Clearing House (ABSCH).
  • Check out the legislative, administrative or policy measures section. If no measures can be found here, the interim reports might also contain relevant information. Tip! filter by country.
  • Be careful though. This information is not always complete or up to date. Some countries have ABS laws but they are not listed in the ABSCH.

To play safe and ensure legal clarity, always contact the ABS national focal point and/or the competent national authority. Tip! filter by country.

No answer?

  • Try contacting the national focal point of the Convention on Biological Diversity (CBD).
  • Ask collaboration partners in the country for help – easier for them to contact the authorities in their own country and language!
  • Ask colleagues who have worked in that country before.
  • Use the internet to find resources.
  • Contact the German Federal Agency for Nature Conservation (BfN). They have information about ABS and may be able to assist.

For research done in Germany, the German Federal Agency for Nature Conservation recommends using the DECLARE portal.

An account is required. Check with your institution as it may already have one.

This video and the user guide are very useful to start!

Starting your project before ABS permits have been granted is a violation of the EU Regulation and can get you in trouble if your institute is being checked by the German National Authority (BfN)!

In this regard, you have obligations under the EU ABS Regulation if:

  • You collected the material…
  • The collaborator who gave you the material collected it…
  • The material obtained from a collection was originally collected…
  • The shop or company where you bought the material collected it…

on or after 12 October 2014

This date is key because it is when the Nagoya Protocol entered into force.

When you obtain material from a collaborator, collection or trader, it is important to verify if there are benefit-sharing obligations linked to it.

For example: research on specific genetic or biochemical properties, gene function, gene expression, genetic modification, genome editing, breeding based on traits and their associated genes, among others.

The EU Regulation does not apply when research does not involve the study of the genetic or biochemical composition, e.g. storing biological materials in a collection, mere culturing of organisms, taxonomic identification, morphological or anatomical characterization, among others.

See the guidance document for more information and examples on “utilisation”.

Also check our FAQs section on it.

ABS obligations may or may not apply depending on the type of research. There could be exemptions for non-commercial or basic research.

Keep in mind that exemptions for local researchers may not apply if they conduct their research abroad (e.g. guest researchers bring material from their home country to study it in Germany).

Within the European Union, obligations stem from Regulation (EU) No 511/2014.

The EU Guidance Document contains information on scope, obligations and understanding whether your material/research is covered, including many practical examples. It is available in all EU languages and is a must-have resource.

Not all countries that are Party to the Nagoya Protocol regulate access, e.g. Germany. In such cases, you are free to use the genetic resources obtained from these countries without getting ABS permits.

You are obliged by the EU and German law to support user checks by the German Federal Agency for Nature Conservation.

Failure to support a user check is an administrative offence.

When you transfer the material to another person or institution:

  • Search if there are ABS documents relating to the material you have.
  • Check if the transfer to third parties is permitted.
  • Transfer also the information, e.g. a copy of the ABS permit or the number of the internationally recognized certificate of compliance (IRCC) published on the ABS Clearing House.

Having a good documentation system will save you headaches in the future.

Read the documents and understand your obligations as well as any conditions and restrictions on use of the material.

Keep in mind your commitments on benefit-sharing!

The due diligence declaration informs the competent authority in Germany that your research and material is Nagoya Protocol relevant and that you have complied with your ABS obligations.

Check out more about it!

“Derivative” means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity.

Some examples are: RNA, proteins (including enzymes), lipids, organic compounds (e.g. essential oils or resins) and other products of metabolism.

Also check our FAQs section on it.

In this regard, you have obligations in the EU if the country where the material comes from was a Party to the Nagoya Protocol and had ABS regulations at the time of access.

Why is ABS important?

Access and Benefit Sharing (ABS) measures ensure that research results support provider countries to:

  • Make informed decisions on conservation, sustainable use and management of their biodiversity.
  • Implement innovative solutions for productive activities, contributing to sustainable development.
  • Build capacities for national research.
  • Other benefits as agreed.

Even if ABS does not apply to your research project, you must be able to provide the German Federal Agency for Nature Conservation with the documentation that supports your conclusion. This will speed up possible compliance checks. Tip! save email correspondence with the provider country authorities on this regard.

For some countries, this can be determined by checking the date of entry into force of the national ABS legislation and compare it with when the material was collected in the field.  If you collected before the legislation went into force, you could be out of scope. However, in some countries “access” can also mean receiving material from an ex-situ collection or even when you start to use it (even if it was collected and left the provider country long ago). Keep this in mind!

Some laws only cover certain types of organisms or organisms collected in certain areas.

Check when:

  • you collect material outside of Germany
  • a collaborator gives you material from another country
  • you get material from a collection in Germany
  • you buy material from a shop or a company
  • traditional knowledge from indigenous peoples or local communities will be used for your research