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DSMZ

Compliance stories

Learning from experience: DSMZ

Type of institution: A public collection of microorganisms and cell cultures

Registered collection under Regulation (EU) No 511/2014: Since March 2018

 

In this compliance story, you can read about DSMZ’s experience with:

  • Deciding to become registered
  • Applying for registration
  • Adapting internal procedures and processes
  • Making sure all samples are Nagoya-compliant

Why did DSMZ become registered?

The Nagoya Protocol is a reality for many researchers and finding out about ABS and obtaining ABS documentation can be very time-consuming. When researchers receive genetic resources from a registered collection, they are also supplied with any relevant ABS documentation by the collection.

For samples in the registered collection, all associated Nagoya Protocol documents, such as prior informed consent (PIC) or mutually agreed terms (MAT), are available to DSMZ’s customers and can be downloaded directly from the product page.

It is an attractive option for DSMZ’s customers from Germany (and around the world) to obtain their material and the associated ABS documentation directly from the collection rather than investing time and energy in the ABS process personally. It makes it easier for them to deal with their due diligence obligations.

Photo: DSMZ

 

Applying for registration

In order to become a registered collection, an application must be submitted to the competent authority in the respective EU Member State. In Germany, this is the Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN). If all the requirements are met, the BfN notifies the European Commission that the collection should be placed on the register of collections.

DSMZ was the first registered collection in Germany and the European Union. The process of becoming registered was therefore new for all involved and there was an ongoing and intense exchange with the BfN during the process.

DSMZ applied for recognition as a registered collection in November 2017. The free text application of approximately 14 pages included:

  • a description of the collection, the types of resources held and the part of the collection to be registered;
  • a list of standardized procedures, including quality management systems, good scientific practice rules etc.;
  • a description of the changes made to existing documentation, .e.g. the DSMZ’s standard terms and conditions and material transfer agreement;
  • a description of the new standard operating procedure for implementation of the Nagoya Protocol for deposits in the collection;
  • a description of record keeping and the use of identifier numbers for tracing purposes;
  • information about training for relevant employees. i.e. to inform them about the new requirements and procedures; and
  • information about how DSMZ’s customers are informed about the Nagoya Protocol and their obligations.

 

The application included a copy of all documents and screenshots of relevant parts of the catalogue etc.

What are the lessons learned?

The application for recognition as a registered collection must focus on the systems and procedures in place to check for Nagoya Protocol relevance, that relevant documentation has been provided by the depositor, that this information is transferred to customers and the information and samples are traceable.

There were no set forms etc. for the registration process. The ongoing and transparent exchange throughout the process with the competent authority was key to the process.

The application process required significant personnel and financial investments. It took collection staff about 4 months to prepare this application and required input from various departments, including the legal department, collection managers, IT etc.

Deposition and purchase of material from DSMZ

DSMZ adapted its internal procedures and documentation and created new procedures to make sure all future deposits are Nagoya compliant.

The new procedure for deposition is:

  • The digital accession form asks for relevant information, namely the county of origin and date of collection.
  • The digital form links to the ABS Clearing House and automatically checks whether the country of origin was a Nagoya Protocol country at the time of collection.
  • If so, the depositor is asked for information about ABS. Information about ABS must be provided, e.g. if there was an exception (ABS was not relevant) or the relevant ABS documents must be uploaded directly by the depositor.
  • The in-house lawyer checks the document and confirms with the national focal point of the country of origin that the ABS documents provided allow the material to be deposited and distributed to other researchers for basic research.
  • If a resource is not in scope of the Nagoya Protocol, it is marked in the DSMZ catalogue as “There are NO known Nagoya Protocol restrictions for this strain”.

Screenshot from the DSMZ’s catalogue

The amended Material Transfer Agreement explicitly requires the customer purchasing the relevant material to agree to:

  • use the material for non-commercial research purposes only;
  • not to distribute material to third parties;
  • to download, read and store the ABS documents from the catalogue for 20 years after their last use; and
  • adhere to the terms listed in the “Nagoya Restrictions” section of the catalogue.

What are the lessons learned?

When setting up the system, thought needs to be given to practical issues like how to deal with samples from states that no longer exist, samples with imprecise geographic information, dependent territories etc. Duplicates and spelling errors also need to be addressed.

DSMZ has contacted all CBD Parties to ask what would need to be done in order to accept a microorganism from their country for deposit in the collection. A database of information on national ABS measures is being built up but for some countries, it is not possible to get information about ABS or information is not available in English. This makes legal deposits from some countries impossible.

Some countries do not allow deposited material to be transferred to third parties. Such samples cannot be accepted into the collection.

Although ABS documentation is provided by DSMZ together with the material, it must be clear to customers that they are still responsible for their due diligence obligations.

The DSMZ created several pages of content on its website to help depositors and customers purchasing material to understand the new requirements, including explanations of important terms and restrictions and an infographic to explain the minimal requirement for deposits.

Cleaning up – checking the existing collection for Nagoya Protocol relevance and compliance

In order to include existing resources in the registered collection, DSMZ checked all resources listed in its public catalogue for Nagoya Protocol relevance and compliance.

DSMZ used two main criteria to work out whether a resource is in scope of the Nagoya Protocol, namely geographical scope and temporal scope.

 

Geographical scope

DSMZ has ensured that the country of origin is known for all strains in the catalogue which were collected in 2014 or after that. Strains with an unknown country of origin were are only accepted if they pre-date the Convention on Biological Diversity and ABS.

 

Temporal scope

All strains in the catalogue that had no sampling date information and an accession date after 1992 were reviewed. The DSMZ used information from the deposit form, literature and internal records to determine a sampling date. When this was not possible, the accession date (when a strain was deposited) was used instead with the note ‘sampled before + accession date’.

Start as soon as possible with the clean up! The sooner you start, the smaller the number of records to be processed (because no further records accumulate) and the higher the chance of being able to find any missing information.

Temporal and geographic information are sufficient to work out Nagoya Protocol relevance. Only a small fraction of samples may require further action or to be removed from the collection. Cleaning up old collections may seem like a daunting task but may not be as bad as one expects.

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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