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Vietnam

ABS stories

Learning from experience: Vietnam

Slide Just 4 months to get the ABS permit!

Institution: A German university

Biological material:  Fecal samples (Limestone langurs)

Research field: Biology

Research: Basic, non-commercial

Focus: Sequencing technology and analysis was applied to understand the microbiome diversity between the limestone and forest langur. This research is being conducted as part of a PhD by a Vietnamese student in Germany. The species involved are endangered in Vietnam.

Collection: The material was collected in the field by research assistants, forest rangers at the relevant nature reserve and the Vietnamese PhD student.

Collaboration partner: Two universities (one in Germany and one in Vietnam)

Funding: Deutsche Forschungsgemeinschaft

 

Photos: Truong Nguyen

ABS Process

Time needed for first response from the National Focal Point: 4 weeks

Time needed until all ABS documents were obtained: 4 months

ABS documents needed: An agreement with the local authorities (provider) ABS permit from MONRE

Other documents needed: cooperation agreement with the local university, project implementation license, export (CITES) permit

Useful information about ABS in Vietnam can be found in the ABS Clearing House and on the national ABS website of Vietnam.

As a collaboration with a local institution is a pre-condition to starting the ABS process, a memorandum of understanding (MoU) was signed by the German and Vietnamese universities.

The ABS process then involved three main steps: First, a request for a project implementation license was submitted to the Ministry of Agriculture and Rural Development (MARD). This request was supported by an official letter from the Vietnamese partner, a copy of the research proposal (in Vietnamese and English), and the MOU. MARD responded within about a week.

In the second step, the project implementation license from MARD was submitted to the local authorities in the area where the field work was to take place. These authorities were the provider and agreed to the implementation of the project.

In the last step, all of the documents, including the documents issued from MARD and the local authorities, were packaged together and submitted to the Ministry of Natural Resources and Environment (MONRE) with the request for an ABS license.

 

Photos: Truong Nguyen

Benefit-sharing

What benefits were agreed to?

  • Reporting of final results of the analysis to stakeholders and local authority in the study area
  • Enhancing our understanding of the biodiversity in Vietnam, especially about the gut microbiome and food plants of the langur species
  • Training for exchange students and working on joint sub-projects
  • Exchange of biological samples
  • Sharing the results among the collaboration partners
  • Co-authorship of publications by the Vietnamese and German researchers

Advice for other researchers obtaining biological material from Vietnam

The university had a positive experience with ABS in Vietnam. What do they suggest?

Contact the national focal point to find out what you need to do and be transparent with the authorities about your work.

Having a collaboration partner in Vietnam and a collaboration agreement is a precondition to starting with the ABS process. Start early with identifying who to work with and with the negotiations of the collaboration agreement. If you do not have a  previous collaboration, this process could take some time.

It can be very helpful to have your collaboration partner in Vietnam support the ABS process, including direct communication with the authorities and providing supporting documentation if necessary.

The Vietnamese authorities do not accept all of the application documents in English. Be aware that some documents must be translated into Vietnamese and these translations must be certified.

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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