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Vietnam

ABS stories

Learning from experience: Vietnam

Slide Just 5 months to get the ABS permit!

Institution: An institute in Germany focusing on marine research

Biological material: Macroalgae, i.e. seaweed

Research field: Biochemistry

Research: Basic and applied research, non-commercial

Focus: The diversity and abundance of macroalgae, potential uses for the cosmetic industry and cultivation techniques.

Collaboration partners: The material was shared among all five project partners, including four research institutions (one in Germany and three in Vietnam) and one German industry partner.

Getting the material: Whole specimens were collected in the field by the Vietnamese partners and scientists from the German research institute.

Funding: Private

Funding period: 2018-2020

Photos: M. Teichberg

ABS Process

Amount of time invested full time in the process: 4 weeks

Time needed until all ABS documents were obtained: 5 months

Time needed for the ABS application to be processed: 3.5 months

ABS documents needed: Prior informed consent (research agreement), a benefit-sharing agreement, an ABS permit, a Material Transfer Agreement between the entities providing and receiving the material

Other documents needed: Research permit, collection permit

Before starting with the process, advice on ABS was provided to the German scientists by another person from the same institution.

A research agreement between the German and Vietnamese research institutes was a precondition to starting the ABS process. This agreement was considered to be Prior Informed Consent (PIC). Finalizing this agreement actually took longer than ABS process itself. Once this agreement had been signed by the directors of all research institutions, the process moved forward.

There were then two main steps, involving registration and submitting an application for an ABS permit.

The Vietnamese partners supported the entire process, although there was also some direct communication between the Vietnamese authorities and the German research institute by way of email. The Vietnamese authorities always responded quickly.

The ABS permit was provided by the Ministry of Natural Resources and Environment.

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

Photos: M. Teichberg

Benefit-sharing

The benefit-sharing arrangements are laid out in two agreements. One agreement is between the industry partner and the German research institute and the other agreement is between the German research institute and the Vietnamese partners (in which the role of the industry partner is also defined). If the industry partner applies for any intellectual property rights, the benefits will be shared with the German research institute. The second agreement ensures that the German research institute shares these benefits with Vietnam.

The scientists sought legal advice from the in-house legal department and external advisors when developing these agreements.

What are the benefits so far?

  • Sharing results among the collaboration partners
  • Co-authorship of publications by the Vietnamese and German researchers
  • Provision of funding for international visits to Germany to process samples together, discuss the project with the partners, and introduce the Vietnamese scientist to the industry partner
  • Provision of funds for research infrastructure and equipment for the collaborating Vietnamese institutions

 

If the project moves into a commercial phase, it is expected that the seaweed farmers and local communities in Vietnam would benefit due to development of a new value chain.

Advice for other researchers obtaining biological material from Vietnam

The research institution in Germany had a positive experience with ABS in Vietnam, although there were some of the usual challenges, e.g. language barriers and not knowing how to go about the ABS process.

What do they suggest?

Plan enough time for the ABS process, be patient and go step by step. Especially putting together the agreements with the different institutions took a lot of time. Consider which steps can be taken early, e.g. before your research project is approved or even before you start writing the project proposal!

Even your local partners may not be familiar with the ABS process or sure how to proceed. Contact the national focal point to find out how the process works and be transparent with the authorities about your work.

Take into account local cultural differences and know how you are going to deal with language barriers. Your local collaborators will play an important role in this regard. Without the research partners in Vietnam, coordinating this ABS process with the local authority would have been very difficult.

Consider getting legal advice. In this case, it was necessary for developing the agreements between the research institutes and the agreement between the German research institute and the industry partner.

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Registered collection

 

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