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Kiel University

Compliance stories

Learning from experience: Kiel University

Type of institution: A public university in Germany

Compliance strategy: Kiel University has developed a strategy to address Nagoya Protocol compliance with three core focus areas:

  • institutional policies

 

  • awareness raising

 

  • tracking system

Institutional policies

Internal guidelines are currently being developed which clearly divide the responsibilities and tasks between the key players. These are:

  • the principal investigators or senior scientists with permanent positions
  • the Nagoya Protocol compliance officer

 

A goal for the future is to pass these internal guidelines through the senate and the presidium of the University to ensure they will be binding for employees.

 

Principal investigators or senior scientists with permanent positions

All researchers at Kiel University are expected to ensure that their research is Nagoya Protocol compliant. Principal investigators or senior scientists with permanent positions are responsible for submitting due diligence declarations. They are also responsible for obtaining ABS documentation, including signing benefit-sharing agreements.  This is intended to ensure that the material can continue being used at the university when researchers in temporary positions leave.

 

Nagoya Protocol Compliance Officer

Since: 2017, officially in the role as compliance officer since April 2019

Department: central administration, catering to all 8 faculties

Time dedicated to role: 2017-2019 (50%), 2019-present (25%)

Contact: nagoya@uv.uni-kiel.de

Main duties:

  • Provide researchers with general information about ABS and the Regulation (EU) No 511/2014
  • Support researchers with acquiring ABS documentation
  • Support researchers with submitting their due diligence declarations

 

The compliance officer is also active in the German Nagoya Protocol HuB Network.

What are the lessons learned?

Although there is a compliance officer who provides support, it is important that the individual researchers still understand that they are responsible for obtaining any ABS documentation and fulfilling the due diligence obligations.

High level institutional support for compliance and the role of the compliance officer is key.

Institutions should consider having procedures in place to deal with difficult cases.

 

Awareness-raising

There are three main elements to the awareness-raising campaign at Kiel University:

  • a webpage
  • presentations
  • targeted emails

 

Website

Kiel University has a public website about the Nagoya Protocol (in English and German).

It provides basic information about researchers’ obligations and the legal consequences of non-compliance, a checklist to determine whether the proposed use of the material falls within the scope of Regulation (EU) No 511/2014, a standard material transfer agreement (MTA) for Nagoya Protocol relevant material and the contact details of the compliance officer.

The content took several months to develop and involved support from the competent authority in Germany, the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN). Since the website was launched, the enquiries received by the compliance officer have become more concrete because the information on the website covers researchers’ basic questions.

Presentations for administrative staff and researchers

Presentations for administrative staff :

  • 20 minutes
  • provide information on why the Nagoya Protocol is important and how it affects research activities at the university
  • the role of the compliance officer is explained
  • emphasis is placed on the importance of collaboration between the compliance officer and the Technology Transfer office in order to ensure that any biological material leaving or coming into the university is checked for compliance

 

Presentations for researchers (employees and students) :

  • 90 minutes, including 45 minutes for questions
  • provides basic knowledge about how the Nagoya Protocol affects their day to day research activities
  • Addresses definitions, the question of scope and common misconceptions

 

Targeted Emails

Targeted emails were sent to 38 Professors who were identified as being potential “users” within the meaning of Regulation (EU) No 511/2014.

While not all recipients responded to these emails, this awareness-raising activity led to a number of requests being made to the Nagoya Protocol Compliance Officer for more information or researchers sought clarification on whether their research falls within the scope of the EU law.

What are the lessons learned?

The information provided on the website and in presentation has to be formulated in easy to understand language – speak the language of your target audience! Different target groups may also need different messages, e.g. communicating to researchers is different to communicating with the university administration.

Although the information provided must be comprehensive enough to ensure there are no misunderstandings, it is important to avoid overloading researchers and confusing them with too much information, especially in the beginning.

Due to the international nature of research at the university, information on compliance has to be provided in both English and German.

PhD students and early career scientists may be more receptive to new compliance requirements that could affect their future careers. Focusing on a strong bottom-up strategy to engage and inform the “younger generation” can enhance understanding and compliance.

Tracking system

There are three main different elements to the tracking system at Kiel University:

  • decentralized document storage
  • a modified material transfer agreement (MTA)
  • a centralised DECLARE account

 

Decentralized document storage

Researchers are responsible for storing ABS documentation.

If research does not fall under the scope of the Regulation (EU) No 511/2014, researchers are required to record why this is the case.

 

Modified material transfer agreement (MTA)

The university has developed a modified MTA for any material that is Nagoya Protocol relevant. This was developed together with the legal officer and technology transfer department.

All MTAS relating to biological material are sent to the Nagoya Protocol compliance officer, who checks for Nagoya Protocol relevance before the MTA can be signed by the university.

Legal support on contracts is also provided on an individual basis by the university’s legal department.

 

Centralised DECLARE account

A centralised account for the European Commission’s DECLARE System was set up at Kiel University.

Although researchers are responsible for submitting a due diligence declaration about their research, the university maintains an overview of all declarations submitted through the university account.

What are the lessons learned?

Support from the legal department is important for determining roles and modifying the material transfer agreement. At Kiel University, the responsible lawyer was highly engaged and got actively involved in the process.

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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