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  • GNP HuB
    • About
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    • Podcasts
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  • ABS
    • Understanding the ABS world – infographic
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    • Tools & Resources for ABS
    • ABS Stories
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    • Video: ABS compliance supports your science
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    • User checks
    • Implications of non-compliance
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    • Guidelines for institutions
    • Who can I contact at my institution?
    • Registered collections
    • Compliance Stories
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    • FAQ
    • Mythbusters
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Mythbusters

There are a number of common misconceptions or myths among researchers in Germany about access and benefit-sharing (ABS) and the implementation of the Nagoya Protocol in the European Union. Here we dispel some of these myths.

You have you a question? You might find the answer in our frequently asked questions (FAQs).

Slide Let's bust some myths!

DISCLAIMER: The German Nagoya Protocol HuB is managed by the Leibniz Institute DSMZ- German Collection of Microorganisms and Cell Cultures GmbH (DSMZ). We provide general information on access and benefit-sharing as well as Nagoya Protocol compliance. This information cannot be considered to be of a legal or advisory nature and no responsibility is accepted by the DSMZ for the results of any actions made on the basis of the information provided. Legal decisions by researchers should always be made in conjunction with their institution, director and legal department.

Advice about the application of the EU laws implementing the Nagoya Protocol to your research can be sought from the Competent Authority for Germany, the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz, nagoya-cna@bfn.de).

Myths about access and benefit-sharing

Access and benefit-sharing only relates to biodiversity research - BUSTED

While it is true that principle of access and benefit-sharing comes (ABS) from the Convention on Biological Diversity (CBD), it is a misconception to think that ABS therefore only applies to classical biodiversity research or conservation work.

ABS is relevant for all different types of research using biological material, including pathogen research, plant and animal breeding, and ecological studies etc.

Anyone using (non-human) biological material should ask themselves whether ABS is relevant for them!

I do basic and/or non-commercial research. Access and benefit-sharing and the Nagoya Protocol don’t apply to me - BUSTED

The Nagoya Protocol and ABS apply to all forms of research, including both basic/non-commercial and commercial research.

Some national ABS laws make a distinction between non-commercial and commercial research, e.g. the benefits to be shared are different or the procedure for obtaining material for non-commercial research purposes may be simpler. Some countries make non-commercial research exempt from ABS. This always depends on the country which is providing the material for research.

It is a misconception that ABS and the Nagoya Protocol have nothing to do with you just because you are doing basic/non-commercial research.

Benefit-sharing refers to money. I’m doing non-commercial research so I can't share any benefits - BUSTED

It is a misconception that benefit-sharing only refers to monetary benefit-sharing.

Benefit-sharing can be monetary or non-monetary.

Typical non-monetary benefits include things like sharing results and data, study exchanges, joint publications etc. Countries providing material for research purpose may require these types of benefits to be shared with them in accordance with a benefit-sharing agreement even if you are doing basic and non-commercial research.

There were no access and benefit-sharing obligations before 2014 - BUSTED

While it is true that there are no diligence obligations under the Regulation (EU) No 511/2014 for research material obtained before 12 October 2014, ABS may still apply to material obtained before that date.

The Nagoya Protocol came into force on 12 October 2014 BUT the Convention on Biological Diversity (CBD) was adopted at the Rio Convention in 1992 and has been in force since 1993. The CBD also includes provisions on access and benefit-sharing (ABS) and many countries implemented national ABS laws long before the Nagoya Protocol even existed!

You should also keep in mind that some countries have ABS laws that apply to material collected before 12 October 2014, e.g. their legislation focuses on when the research starts and not when the material was first obtained.

The Nagoya Protocol says that countries around the world own their "genetic resources" - BUSTED

The Nagoya Protocol does not say anything about the ownership of genetic resources.

The Protocol recognizes the right of countries to regulate access to their “genetic resources” and to require benefit-sharing arising from their use. This simply means that these countries can make laws about access and benefit-sharing but says nothing about who actually owns the material.

Ownership will be determined by the national laws of the country. Owners of the material could be, for example:

  • government , e.g. if the material is sampled on public land
  • an individual researcher or the institution where he or she works
  • a private landholder
  • a company
  • indigenous people or a local community

 

Myths about due diligence

My research is funded through my research institution’s core budget. I don’t have any due diligence obligations - BUSTED

If research is third party funded and it falls within the scope of Regulation (EU) No 511/2014, you need to submit a due declaration.

If research is funded from an institution’s core budget and it falls within the scope of the regulation, there is no need to submit a due diligence declaration, BUT all other due diligence obligations still apply.

It is sufficient if your Material Transfer Agreement (MTA) states that your research material is Nagoya Protocol compliant - BUSTED

A material transfer agreement alone is not enough to satisfy your due diligence obligations.

You need to find out whether any ABS laws apply to your material, irrespective of whether you sample the material yourself or you get it from another scientist or collection on the basis of an MTA. If ABS applies, you need to have the necessary documentation, e.g. the permits which allows your research to be conducted (prior informed consent), benefit-sharing agreement etc.

If you are getting the material from someone else on the basis of an MTA, ask them for a copy of the original documentation. You need these documents so that you can:

  • check whether your research is permitted;
  • comply with any requirements in the documents; and
  • transfer them with the material if the material is given to a third party

I already have my research material stored at my institution. I can just use it and don’t have to worry about Regulation (EU) No 511/2014- BUSTED

A number of researchers believe that they can simply use “old” material stored at their institution without making any further enquiries. Not anymore!

If you are planning to do research on the genetic and/or biochemical composition of “old” material and the material was originally obtained on or after 12 October 2014, you might fall within the scope of Regulation (EU) 511/2014.

That means that you need to do your homework. If you know where the material originally came from and when it was sampled, you can work our whether ABS laws applied and what (if any) ABS documentation was required.

If ABS documentation exists, check whether it covers the proposed research. If not (or there is no ABS documentation), you will need to contact the provider country and make arrangements to obtain the necessary ABS documentation before you start your research.

It is complicated to submit a due diligence declaration - BUSTED!

Lodging a due diligence declaration is probably the easiest part of your obligations.

In Germany, it is recommended that you submit your due diligence declaration through the European Commission’s DECLARE portal. Here is the user guide for DECLARE.

How much time do you need?

  • Registering your user account in DECLARE – you need approximately 5 minutes.

Your DECLARE account needs to be approved by the competent authority in Germany and this could take a few days.

  • Lodging your due diligence declaration – you need approximately 10-20 minutes.

My research project was approved/started before 12 October 2014. I am not in scope of the Regulation (EU) No 511/2014 - BUSTED

When your research started or when the funding was approved is not relevant for Regulation (EU) No 511/2014. The relevant question is when the material used for the research was obtained, i.e. “accessed”.

If any of the biological material used in the research was obtained on or after 12 October 2014, your research could fall within the scope of the regulation. That means you need to check whether ABS obligations apply!

Careful! You may also have had ABS obligations under the national laws of the provider country before 12 October 2014.

I checked the ABS laws in the provider country and they don't apply to me. I still need to submit a due diligence declaration - BUSTED

It is good practice to document any enquiry you make into whether ABS applies to you and your research.

If there are no applicable ABS laws or the ABS laws of the provider country do not apply to your research, there is no need for you to submit a due declaration to the German competent authority.

 

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