This is where you can find answers to frequently asked questions that come from the academic sector. If you can’t find what you are looking for, let us know.
For basic FAQs, you can also refer to the website of the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz, BfN).
You can also check out our mythbusters where we dispel a number of common misconceptions or myths among researchers about access and benefit-sharing (ABS) and the implementation of the Nagoya Protocol in the European Union.
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).
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FAQs about access and benefit-sharing
You always need to comply with the laws of the countries where you are working!
Even if the country is not a Party to the Nagoya Protocol, you may still need prior informed consent and to sign a benefit-sharing agreement. There are examples of countries that have ABS laws but which have not yet ratified the Nagoya Protocol, e.g. Costa Rica, Australia, Brazil. You should always check the national requirements before obtaining your material and starting any research.
If your research material comes from a non-Nagoya Protocol country, you won’t have any due diligence obligations in Germany as the material falls outside the scope of the EU Regulation.
It is sometimes possible that citizens of a country do not need to follow access and benefit-sharing (ABS) laws, i.e. they are exempt. Sometimes the requirements for local scientists may be more relaxed than for foreign researchers. Using the material in Germany for research could be subject to different rules. This may also be the case even if a local researcher country brings the material with them to Germany.
There are some ABS systems that require administrative fees to be paid. Ideally, these should be transparent and listed on the website of the responsible authority. If administrative fees apply, you should check with your funding agency whether these fees can legally be paid under your grant agreement.
There are different types of benefits that can be shared, including monetary benefits like royalties or profit-sharing, and non-monetary benefits like sharing results and data, study exchanges, joint publication etc.
National ABS regulations often list the types of benefits that can be shared.
Benefit-sharing obligations typically apply to both non-commercial and basic research.
Individual benefit-sharing agreements always have to be negotiated by the parties involved, which means that it is not possible to say in advance what sorts of benefits will be shared through a non-commercial research project.
The types of benefits that you can share need to be clearly communicated to the relevant authorities in the provider country. You should always check that what you agree to is also consistent with your grant agreement.
Some benefit-sharing agreements do include clauses on commercial use and paying royalties etc., which do not necessarily apply to the basic researchers. These obligations, however, can be triggered if the material and these obligations are passed on to subsequent users of the material and these third parties use it for commercial purposes.
Each Member State of the European Union (EU) has to implement the compliance measures in Regulation (EU) No 511/2014. However, each country can decide whether to regulate “access” or not.
There are some countries in the European Union, like Germany, that do not regulate access.
Some countries in the EU have decided to regulate access, for example, France, Croatia and Spain.
If there are access regulations in EU countries, German researchers have to follow those rules. If you are planning to use material from an EU country for your research, you should check whether any ABS laws apply.
Different parts of the government are responsible for different things. The ABS laws and regulations in a country will specify which government department is responsible for providing you with prior informed consent (PIC) and your ABS permit etc.
ABS obligations are additional to a research permit, export permit, CITES, phytosanitary certificate etc. The documents are often issued by different parts of the government. For example, your research permit may come from the Research Ministry and the ABS permit may be issued by the Environment Ministry.
Some countries are working towards creating an online portal where all of the permits you need can be applied for at the same time, e.g. Kenya and India.
FAQs about which material is Nagoya Protocol relevant
The Nagoya Protocol does not differentiate between wild and domesticated samples. In theory, a country may include both in its national ABS laws. Some countries have chosen only to regulate access to wild species, others include only native species, and in some countries both domestic and wild species are included in the national laws.
Just because a sample comes from a domestic sources, e.g. provided by a zoo or from a commercial breeder in another country, it does not necessarily mean that ABS does not apply. It always depends on the national law – you have to check!
The human microbiota refers to all microorganisms residing on or in the human body whereas the ‘microbiome’ is the collective genomes of all of those microorganisms (bacteria, viruses, fungi etc.).
The human microbiome is non-human, which means that it could be Nagoya Protocol relevant.
In the European Union, research on microbiota is out of scope of Regulation No (EU) 511/2014 if:
- it is studied in situ (i.e. in or on the body);
- the focus is on the unique composition of the microbiota of an individual;
- it only involves taxonomic identification.
Research on microbiota is considered to potentially be in scope of the Regulation if the research takes place on individual taxa isolated from a sample and it is no longer part of the unique microbial composition of an individual person.
Which country is the provider country?
According to the EU Guidance document, the provider country of the microbiome is Germany if:
- a sample is taken from someone who has been in Germany, even if the person is a resident of another country;
- samples are taken from sewage samples in Germany.
Germany will not be the provider country if:
- samples are sent to Germany by a laboratory in another country. In this case it will be the country where the sample was collected/taken.
- the sample is collected immediately after a person arrives in Germany. In this case, the provider country is considered to be the person’s country of residence.
A commercial plant variety is considered to be any plant variety that has been legally placed on the market in the EU, whether it is still available on the market or not.
For a commercial plant variety, there will be systems in place for its identification and characterization, such as:
- the variety has been legally protected by a plant variety right under EU or national law;
- the variety has been registered in a national or common catalogue of varieties of agricultural plant and vegetable species, or in a list or register of forest reproductive material, fruit or vine varieties;
- the variety has been entered in any other public or private list according to EU legislation and/or international standards containing officially recognised denomination and description.
Use of such commercial plant varieties for subsequent breeding programs does not fall within the scope of Regulation (EU) No 511/2014 as breeders are considered to be relying on a new and different genetic resource.
If Nagoya-relevant material was used to develop the variety, benefit-sharing obligations may continue to apply between the provider country and the first user of that material.
Laboratory mice are comparable to a “laboratory strain”. What is a laboratory strain?
- They are living organisms;
- They are typically mass produced and often provided by commercial providers;
- They are genetically defined and have low heterozygosity;
- They are distinct from any parent material used in their development as a result of mutation, breeding, selection etc.;
- They are commonly used in research as models.
Laboratory strains created before 12 October 2014 fall outside the scope of Regulation (EU) No 511/2014 for temporal reasons.
Use of laboratory strains as a model and platform for testing is not considered to be utilization and also falls outside the scope of Regulation (EU) No 511/2014.
The initial research leading to the development of a laboratory strain is regarded as utilization. In other words, creating a new or modified laboratory strain could be Nagoya Protocol relevant, depending on where the parent material comes from. The national laws of the provider country will determine whether the material triggers ABS obligations or not.
A newly created strain remains within the scope of Regulation (EU) No 511/2014 until it becomes publicly available to others for research purposes. If the strain has become a new laboratory strain and is shared by laboratories/researchers, its further use then falls out of scope of the Regulation.
Genetic material includes “functional units of heredity”, i.e. genes and the derivatives derived through the expression of those genes. The Nagoya Protocol does not differentiate between material that is living, dead (or fossilized for that matter).
You would need to check with the relevant national authority as to whether fossilized DNA, proteins etc. fall within the scope of their national ABS legislation.
For the Regulation (EU) No 511/2014, it is not the age of the material that triggers obligations but the date that it was obtained, i.e. accessed, in a country.
Whether DSI falls within the scope of the Convention on Biological Diversity (CBD) and the Nagoya Protocol or whether benefit-sharing obligations apply is being discussed at the international level.
Some countries have taken the position that DSI is within scope and have started to regulate DSI at the national level.
The European Union has taken the position that sequences in publicly accessible databanks do not fall within the scope of the CBD or the Protocol. If you obtain sequence data from a publicly accessible database, you do not have any due diligence obligations under Regulation (EU) No 511/2014. However, the EU recognizes that the generation of sequences from a physical sample and their subsequent use, transfer, publishing etc. could potentially be subject to conditions and benefit-sharing obligations stipulated in your ABS permit and/or in the mutually agreed terms established with the provider country.
FAQs about compliance in Germany and the EU
If your research falls outside the scope of Regulation (EU) No 511/2014, you do not have to prove it.
It is, however, a good idea to keep records with the sampling date and country of origin for the material you are using and copies of any correspondence or other records that show that your material does not have ABS obligations. This will help you if the German competent authority (German Federal Agency for Nature Conservation, BfN) conducts a compliance check and challenges your claim that you are out of scope the Regulation.
Regulation (EU) No 511/2014 requires you to check whether ABS laws apply to the proposed research in Germany and if necessary, you need to obtain the relevant documents.
It is not uncommon for researchers to receive material on the basis of a material transfer agreement. Not everyone goes out into the field an collects everything themselves.
A material transfer agreement alone is not sufficient to fulfil your obligations under Regulation (EU) No 511/2014.
If you receive material that falls with the scope of the Regulation from another person, e.g. a local collaboration partner, a collection etc., you should ask them to give you a copy of the ABS documentations in addition to the MTA.
Once you have these documents:
- check that the export of the material and the proposed research in Germany are covered.
- Check whether any benefit-sharing obligations apply to you.
Research institutions often have a memorandum of understanding with collaborating institutions in other countries and/or the government of the country where researchers are working. This might take care of issues like visas, transfers of material, sharing of costs etc.
Researchers should not confuse a memorandum of understanding with ABS documentation which is additional.
The national laws of the provider country will determine what is required. You may need to get a permit and sign a benefit-sharing agreement (so-called “mutually agreed terms”).
Were the permits issued to you personally or to your institution? If the permits were issued to your institution and you leave that institution and take the samples with you, this might be regarded as a third party transfer, even though you collected the samples and they are still in in your possession.
If in doubt about whether you are doing the right thing, you could ask your legal department or the authority who issued the permit in the first place.
The end of the research activities will depend on the situation. It could be the point when the physical research activity stops or when the results are finalized/published.
Breeding animals or plants for production or to maintain a sustainable population does not count as utilization, i.e. research and development under Regulation (EU) No 511/2014.
Taking material from a commercial source, e.g. a breeder and using it for research on the genetic and biochemical composition of the material amounts to a “change of intent” and this research could fall within the scope of the Regulation.
How might material provided by a commercial breeder fall within the scope of the EU ABS Regulation?
- The country where the commercial breeder is located may have ABS legislation that regulates access to the material, including material provided by commercial breeders.
- The material used by the commercial breeder to develop its product includes Nagoya- relevant material from another country and there are ABS documents that apply to the subsequent use of this material for research (including for basic and non-commercial research).
You should check with the commercial provider about where the material originally came from. Was it imported from a Nagoya Protocol country and when? Access and benefit-sharing laws could possibly apply.
Simply storing the material at the collection does fall not within the scope of Regulation (EU) No 511/2014 because it is not considered to be “utilization”.
If the material will subsequently used for research purposes, enquiries must be made into where the material originally came from and when it was obtained. The person donating the material should be asked to provide a copy of any relevant documentation.
Simply having time pressure is not considered to be an adequate reason for not complying with your due diligence obligations.
There are no laws in Germany regulating access to material that originally come from Germany. Researchers should keep in mind that other laws, e.g. nature protection laws, might apply.
Regulation (EU) No 511/2014 does not apply to pathogenic organisms or pests present on a human, an animal, a plant, a micro-organism, food, feed or any other material that are introduced unintentionally to the EU, irrespective whether the organism comes from an EU Member State or another country with ABS laws.
Did the person entering the EU simply seek medical treatment, irrespective of whether they knew that they were infected or not? If the pathogen is isolated through the course of the medical treatment, this is considered to be unintentional access and its subsequent use for research is considered to be out of scope of the Regulation.
Did the infected person know that they were infected and entered the EU with intention of participating in a study on that pathogen? If a sample is taken from this person and the pathogen is isolated from a sample for research purposes, the access is considered to be “intentional”. In this case, the provider country is the place where the person participating in the study became infected and not where the sample was taken, i.e. in Germany. Access and benefit-sharing laws may apply – this should be checked before the research commences.
FAQs about who is responsible for due diligence
Collaboration partners in other countries can be very helpful with the ABS process as they are based in the provider country, can speak the local language and if needed, they can personally go into the offices of the relevant government authorities for meetings. You could ask them to support the ABS process although you should keep in mind that they also not be familiar with the process.
As a German researcher, you remain responsible for your obligations under Regulation (EU) No 511/2014. You need to check whether ABS laws apply to the proposed use of the material in Germany and if necessary, you need to have the relevant documentation.
Under Regulation (EU) No 511/2014, it is always the person using the material for research, the so-called “user”, who has to fulfill their due diligence obligations.
There are currently three collections listed in the European Union’s register of collections, including the Leibniz Institute DSMZ.
Registered collections check whether the material held by the collection has been obtained in an ABS compliant way and they provide the recipient of that material with any relevant documentation.
This takes care of the “seeking information” part of your due diligence obligations. However, as a researcher using the material, there are still a number of some things you need to do:
- comply with the requirements and conditions outlined in the ABS documents
- keep the documents for 20 years from the time the research ends
- transfer the documents to any subsequent recipients of that material
- submit a due declaration if the research is third-party funded
If the BfN conducts a check of your institution, you are required to support that process and provide more information etc.
If ABS laws apply to the activities conducted during the summer school, the organizing institution would be expected to obtain the required ABS documentation before the summer school takes place. External lecturers should also ensure that their participation is covered by the relevant documentation.
Sometimes, research takes place in Germany with the material that was collected during the summer school. A paper may even be published.
For the purposes of Regulation (EU) No 511/2014, it is not relevant that the material was collected during a summer school. The question, which is of relevance is whether utilization subsequently takes place in Germany. If so, the people involved in that research will have due diligence obligations. If that research is financed by a third party (public or private) and not through the university’s core funding, a due diligence declaration must be submitted.
Correct. The due diligence obligations under Regulation (EU) No 511/2014 only apply to research done in Germany (and other EU member states) and not in the USA.
Nevertheless, researchers from both Germany AND the USA will have to comply with the national ABS laws of the country that provided the material for research.
In Germany, users are required to submit their due diligence declarations online portal called DECLARE. In most cases, this is done by the individual researchers.
Some institutions have a centralized DECLARE account and all researchers at the institution should submit their due diligence declaration through this account.
When joint research takes place, it is sufficient for one person to submit the due diligence declaration on behalf of all the research partners.
FAQs about what to do if you can’t get information about access and benefit-sharing
Have you found any indication that ABS measures may exist? For example, ABS laws are mentioned in the ABS Clearing House. Then you need to comply with those laws in order to fulfill you due diligence obligations. If ABS laws exist but their application is unclear, researchers should wait for a response from the national authority. Alternatively researchers could consider seeking legal advice, e.g. from local legal practitioners, on the scope of the relevant ABS measures and whether they apply to the proposed research and associated activities. However, there is a risk that this legal advice is not definitive.
What if you have not been able to find any information that ABS laws exist? If you contact the national focal point and/or the competent national authority at least three times over an extended period of time (at least 3 months with approximately a month between enquiries) and get no response, you might be considered diligent from the perspective of the German competent authority – but only in the first instance!
What does this mean? If any information subsequently becomes available that indicates that there are access measures in the provider country that you need to comply with, you are required by Regulation (EU) No 511/2014 “rectify” the situation. You must immediately and indefinitely stop using the material for research until such time as you have obtained the necessary ABS documents.
It is important to keep in mind that “ignorance of the law is no excuse” anywhere in the world. If you obtain and use material for research without first clarifying whether ABS laws apply to you, you may infringe the national laws of the provider country and you could be punished accordingly in that country. Some countries take this very seriously, imposing high fines, refusing future entry to the country (or specific regions) or jail terms for taking biological material without permission and in the absence of benefit-sharing.
In practice, it may take a long time for national authorities to respond to researchers’ enquiries about whether ABS laws exist and if and how they apply in a specific case. The Nagoya Protocol does not have a mechanism for moving things forward in cases where national authorities do not respond or process applications for ABS permits. The options available for addressing these issues, e.g. through legal proceedings in an administrative court, depend on the national laws of the provider country.
Check all of your documents. Making sure that your application form has been filled out properly and all of the supporting documents have been submitted could help.
Regulation (EU) No 511/2014 does not prohibit the use of material when the origin and/or time of access cannot be identified despite best efforts to do so. HOWEVER, you need to be aware that if more information becomes available which allows the time of access and origin of the sample to be identified, you will need to conduct your due diligence (assuming the sample falls within the scope of the Regulation). If you find out that there are access measures in the provider country that you need to comply with, you are required to “rectify” the situation. You must immediately and indefinitely stop using the material for research until such time as you have obtained the necessary ABS documents.
It should be clear to anyone conducting research on the material that they are doing so at their own risk. If the competent authority in Germany conducts a user check, cases where information about the origin of the material and date of access is missing will be investigated and handled on a case-by-case basis.
Ultimately, deciding to conduct research where there is a lack of information is a question of risk for the individual and his or her institution. IF zero information about the origin of the material and the time of access is available, best practice might be, for example, to refuse to accept the material or to store the material in a collection but not to make it available for research.
Universities, research institutes, collections and museums, for example, can have many biological objects for which there is no information associated, e.g. about where it came from, when it came into the collection or who sampled it. In some cases, there may be only very vague information, such as the region it came from.
Information about the date of access and/or country of origin is very important.
There are two key pieces of information that are key to working out whether the material is Nagoya Protocol is relevant, i.e. when the samples were accessed and in which country. This might be relatively straightforward or it may need some “detective” work.
There may be multiple sources of information that could be used as proxies to work out when the material was obtained and where the material came from.
Date
What kinds of data sources can be used to determine when samples were obtained?
- Are there any records of this material being used in an experiment?
- Is the sample mentioned in a publication and if so, when was this first published?
- Is the date of collection mentioned in a publication?
- When were the last collecting trips to the provider country conducted?
- If the material is at a collection, is there a date on the accession form?
- Who used the material? Have they left the institution and if so, when?
Was any of this before the Nagoya Protocol came into force on 12 October 2014? If so, it could be assumed that the samples were obtained before this date and cannot fall under the Regulation (EU) No 511/2014.
It is important to keep in mind that even though a sample may fall outside the scope of the EU law, the ABS laws of the country where it came from may still apply.
Origin
It is possible that some of the data sources mentioned above may also reveal where the material came from? Can your research tell you anything about where the sample may come from? Is it a widely distributed species or is it endemic to a particular country?
Your research may be able to narrow down the origin of the material to a specific country.
If the shipment can be traced, it could be possible to determine where the organism came from. If so, it should not be used for research without conducting due diligence. That means checking whether any ABS rules apply in that country and if necessary, obtaining ABS documentation.
Storage of the specimen, e.g. at a museum and identification of the species does not count as utilization under the EU Regulation. If this is all that happens, no due diligence obligations apply.
FAQs about what types of research are considered to be “utilisation”
Advice about the application of the EU laws implementing the Nagoya Protocol to your research can be sought from the National Competent Authority for Germany, the German Federal Agency for Nature Conservation (Bundesamt für Naturschutz, nagoya-cna@bfn.de).
According to Regulation (EU) No 511/2014, collection of biological samples is not considered to be utilization. That means you have no due diligence obligations if you are only collecting.
Subsequent use of the material for research may result in due diligence obligations.
Caution! Many countries with national ABS laws consider collection of the material to be ABS relevant. You will still have to comply with their national laws when in the field.
According to the Regulation (EU) No 511/2014, storing and/or displaying material does not constitute utilization.
The identification and classification of organisms is not considered to be a form of utilization under Regulation (EU) No 511/2014 as long as the research does not investigate the genetic or biochemical composition of the organism.
Careful! Taxonomic work often falls within the scope of national ABS laws of provider countries. You may require an ABS permit and to sign a benefit-sharing agreement.
Where there is no research into the genes, the function of the genes or (new DNA sequences), the construction of a phylogeny is considered to be out of scope of the Regulation (EU) No 511/2014. The analysis of so-called “marker genes” to interpret phylogeny when it is conducted independent of the function of the genes does thus not trigger due diligence obligations. The use and interpretation of results of the phylogenetic tree to generate new knowledge could trigger utilization. The exact transition from phylogeny/taxonomy to utilization must be handled on a case-by-case basis.
Caution! Sequencing and the use of the sequences to construct the phylogeny might be covered by national ABS legislation and this should be checked.