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  • ABS
    • Understanding the ABS world – infographic
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France

ABS stories

Learning from experience: France

Slide All done in 3 months!

Institution: A German University

Biological material: Brown algae

Research field: Biochemistry, bioprospecting, basic medical research

Research: Basic, non-commercial

Focus: Extracts from the algae were created, characterised and put into a database. These were screened for the most promising candidates, which were then tested for their suitability in the fields of ophthalmology (age-related macular degeneration), regenerative medicine (tissue engineering) and cosmetics.

Collaboration partner: There were eight partners from Germany and other European countries in total, including research institutes, universities and partners from the private sector.

Collection: The material was sold to the German university by a private company in France.

Funding: European Union (Interreg)

Funding period:  2017-2020

 

 

 

 Photo: Zenthoefer

ABS Process

Time needed for first response from the National Focal Point: 1 day

Amount of time invested full time in the process: 4-5 days

Time needed until all ABS documents were obtained: 3 months, including the time needed for the partners to gather the information needed for the application and the processing time by the French authority. This application was prepared and lodged towards the beginning of the Corona pandemic, so this may also have slowed the process slightly.

ABS documents obtained: National ABS Permit 

Before starting with the process, advice on ABS was provided to the German scientists by the Nagoya Protocol compliance officer at their institution.

In the first step in the process, the scientists contacted the French National Focal Point. It took about one day for this person to respond to their initial enquiry.

The application involved filling out a “declaration form” (Déclaration pour l’accès aux ressources génétiques d’espèces animales non domestiques ou végétales non cultivées, et le partage des avantages découlant de leur utilisation). This form includes questions about the purpose of the research, the place of collection, the type of genetic resource, questions about benefit-sharing as well as general information about the institution (research location). These forms are in French but could be filled out in English.

The only ABS document needed was an ABS permit, which was issued by the French Ministry of Ecological and Solidarity. This document refers to the project and covers the participation of all eight collaborating institutions in the research.

An internationally recognized certificate of compliance has been published in the ABS Clearing House.

The ABS procedure for non-commercial research is described in English in the ABS Clearing House. The French Ministry has also made information about ABS in France and courtesy copies of the relevant law and regulation available in English.

 

 

 

 

Photo: Zenthoefer

Benefit-sharing

There was no additional benefit-sharing agreement in this case. All of the benefits to be shared are listed in the ABS permit and include:

  • conferences, including for the general public
  • scientific publications

Advice for other researchers obtaining biological material from France

The research institute had a positive experience with ABS in France. The communication with the French authorities was open and quick.

What do they suggest?

ABS can also apply to material obtained from commercial sources. Even if you buy material from a commercial provider, you should check whether ABS applies to you and if so, you should follow the ABS process. In this case, the algae were bought from a company.

Contact the national focal point to find out what you need to do. Be transparent with the authorities about your proposed research.

Inform yourself about your responsibilities, e.g. by contacting the responsible person at your institution, and plan enough time for the ABS process. It may take some time so it is good to start early!

Know how you are going to deal with language barriers! In this case, the German scientists sought help with the French language from their collaboration partner from France.

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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