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User checks in Germany

User checks are conducted to ensure that research in Germany is compliant with Regulation (EU) No 511/2014.

Podcast: User checks in Germany

Check out our podcast where Elizabeth Karger of the German Nagoya Protocol HuB speaks to the head of the Nagoya Unit at the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN) about these checks, their purpose, the process and some of the lessons learned.

Who is responsible for checking compliance?

Compliance checks under Regulation (EU) No 511/2014 are always organized at the national level. The competent authority in Germany is BfN.

A number of provider countries monitor researchers and companies around the world to detect illegal use of their biological material. They scan patent databases or journal publications for evidence of research. Some countries also have control checks at their borders to ensure that material is not exported illegally. In cases of non-compliance, they may take action according to their own national laws.

Why am I being checked?

Slide Why me?

There are two different reasons why a researcher or an institution may be subject to a user check by the BfN.

  • Regular user checks are conducted according to the BfN’s risk-based control plan, which is periodically reviewed and adapted. In accordance with this plan, user checks in the academic sector started in Germany in September 2020.

 

  • User checks are also conducted if there are substantiated concerns that an infringement of Regulation (EU) No 511/2014 law has occurred.

Regular user checks might lead to substantiated concerns of non-compliance at other institutions, for example, if non-compliance at collaborating institutions is detected.

How are users in the academic sector selected?

For the BfN’s  first risk-based control plan, twenty institutions from the academic sector were randomly chosen. The BfN then attempted to determine whether researchers at these institutions are likely to be “users” within the meaning of the EU law and to determine the risk of non-compliance for each institution. To do so, BfN checked a number of sources, including institutional websites, press releases, publications of research results and patent databases etc. On this basis, ten institutions were selected for the user checks.

If you are interested in gaining more insight into user checks, you can find more information about user checks in Germany and how they evolved in the reports of the first and second Meetings of the European Competent National Authorities Implementing the Nagoya Protocol and the Corresponding EU Regulation, published by the BfN in 2017 and 2018.

What happens during a user check?

You are obliged by the EU and German law to support a user check. For more information about your obligations under the EU law, see here.

The more transparent you are and the better your ABS documentation system is, the quicker a compliance check can be finalized.

A user check is a process that can take a number of months, with correspondence going back and forth between the BfN and the relevant institution or researcher.

 

What can I expect to happen?

1.

Your institution receives a letter explaining that it is being checked. This letter explains the purpose of the check, the legal basis for it as well as providing a form to fill out with a number of questions.

The questions relate to different topics:

  • the levels of awareness about Regulation (EU) No 511/2014 and compliance obligations

 

  • the preparedness of the researchers to fulfill their due diligence obligations

 

  • activities at the institution that might be in scope of the EU law. These questions relate to the samples used at the institution, the type of research conducted and the ABS information that has been obtained with respect to these samples

 

  • information can also be provided about what steps the institution has taken towards compliance management, e.g. designation of a responsible person, internal policies and procedures etc.

2.

Once you have filled in the survey and returned it, it may be that BfN will have more specific questions in order to clarify information, confirm joint understandings or possibly challenge information provided. Further information may be necessary, for example, about specific research projects and the samples used. This information is usually provided in writing and you may be required to provide copies of documents.

3.

Depending on the information provided the BfN may have further questions, conduct an on-site inspection or conclude the user check.

Do you have enough time to organize the response to the BfN? If not, you might consider requesting an extension. Don’t forget to let them know why you need more time!

The BfN must comply with data protection laws and business and operational secrets must be treated confidentially.

 

 

What happens during an on-site check?

During a following on-the-spot check (visit in person), authorised persons from the BfN can:

  • enter and inspect property, commercial and business premises during operating and business hours

 

  • inspect documents and make copies of them

 

  • carry out examinations, including taking samples of material

Other useful resources

BfN: The BfN page on legal questions covers a range of topics including questions about user checks.

The German Alliance ABS advisory platform for academic research is funded by members of the Alliance of Science Organisations. The project sponsoring members of the Alliance are the German Research Foundation (DFG), the German Rectors’ Conference (HRK), the Helmholtz Association of German Research Centres (HGF), the Leibniz Association, the German National Academy of Sciences Leopoldina and the Max Planck Society.

 

 

 

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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