Whether you have compliance obligations in Germany is determined by EU law, i.e. Regulation (EU) No 511/2014. There are different elements that need to be considered:
- the type of material you are using (don’t forget that the regulation also applies to associated traditional knowledge)
- where the material comes from
- when the material was originally obtained
- what type of research you are doing
These elements are cumulative and you need to address all of them in order to work out if Regulation (EU) No 511/2014 applies to you or not.
Who has obligations?
Regulation (EU) No 511/2014 applies to both commercial and non-commercial or basic researchers.
The regulation also applies to both individuals and legal entities that fall within its scope – that includes academic institutions like universities and public research institutes.
Regulatory bodies carry out a number of tasks in relation to food safety, human, animal and plant health, and/or product quality that could potentially fall within the scope of the regulation. These bodies are not exempt just because they are carrying out tasks for the German government.
Caution! Regulation (EU) 511/2014 is not necessarily a 1:1 match with the national laws of the country where your research material comes from. That means that the laws of the provider country might apply to you but the EU law does not. In this case, you still need to comply with your national ABS permit and your benefit-sharing agreement but do not have any additional compliance obligations in Germany.
The type of material
The Nagoya Protocol and Regulation (EU) No 511/2014 do not refer to biological material
Regulation (EU) No 511/2014 refers to “genetic resources”. Biological material probably sounds much more familiar to you but it is important to understand what is meant by a “genetic resource”.
Genetic resources – what are we talking about?
“Genetic resources” are:
- genetic material – this includes material of animal, plant, microbial or any other origin that contains functional units of heredity, i.e. genes AND
- that material has actual and potential value
Don’t be confused by the word “value”. Genetic resources include material used for non-commercial research.
“Genetic resources” are NOT:
- human (but the human biome may be covered) OR
- plant genetic resources in Annex I of the International Treaty on Plant Genetic Resources for Food and Agriculture (“Plant Treaty”)* OR
- pandemic influenza strains covered by the Pandemic Influenza Preparedness Framework (“PIP Framework”)*
* This material may fall under the EU Regulation if:
- the material is obtained from a country that is not Party to these two international agreements but it is a Nagoya Protocol country OR
- the material is used for a purpose not covered by these two instruments.
It’s not just about DNA!
Research on naturally occurring biochemical compounds that result from the genetic expression or metabolism of “genetic resources” are also covered. In the ABS world, these compounds are referred to as “derivatives”.
What are examples of derivatives?
- proteins
- enzymes
- lipids
- flavonoids, essential oils or resins from plants.
Regulation (EU) No 511/2014 only applies to a derivative when there is a recognizable level of continuity between the derivative and the material from which it was obtained. In other words, the derivative must be obtained (or “accessed”) in combination with the genetic resource.
Continuity?
According to the EU Guidance Document, continuity between the “genetic resource” and a derivative exists where:
- the research on the derivative forms part of research on a genetic resource OR
- you, your collaboration partner or a service provider obtains the derivative from a genetic resource for the purpose of your research OR
- you get the derivative from someone else and there are already access and benefit-sharing obligations that cover further research on that biochemical compound
According to the EU Guidance Document, there is no continuity if:
- the derivative is acquired from a third party as a product available on the market AND
- the derivative is acquired without any access and benefit-sharing obligations that covers the proposed research on the derivative.
A number of countries do not treat derivatives the same way as the European Union. The national ABS laws of the country where the material originally came from might apply to derivatives that are accessed separately from the “parent” material, i.e. you obtain only the biochemical compound. Remember to comply with the national ABS laws of the provider country, even though the EU Regulation does not apply.
What does the EU Guidance document say about the type of material covered by the Regulation?
According to the Guidance Document, laboratory strains are out of scope of Regulation (EU) 511/2014.
The Guidance Document refers to laboratory strains as living organisms that are typically mass produced and often provided by commercial providers. Furthermore, they are genetically defined, have low heterozygosity and are distinct from any parent material used in their development as a result of mutation, breeding, selection etc.
These laboratory strains are commonly used in research as models and have been in use for many years (sometimes decades).
Strains created before 12 October 2014 fall outside the scope of Regulation (EU) No 511/2014 (already) for temporal reasons.
The EU Guidance document refers to human microbiota as 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 regarded as being non-human, which means that it could be Nagoya Protocol relevant.
The Guidance Document indicates that research on microbiota is out of scope of Regulation (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.
Many specimens have other organisms on or in them, e.g. parasites, pests, pathogens, symbionts and the microbiota. The EU Guidance Document refers to these organisms as “associated organisms”.
If you access one organism but then do research on an associated organism, Regulation (EU) 511/2014 would apply (assuming the material falls within its scope).
The Guidance Document does note that in some cases, it may not be clear where the association took place (in other words where the organism was “picked up”), which could make it impossible to identify the provider country.
Material held privately could potentially be Nagoya Protocol relevant.
Traded commodities that are used in their original commercial sense are not relevant for Regulation (EU) No 511/2014”. However, taking a traded commodity that was, for example, intended for consumption and using it for research is considered to be a change of intent. The material could potentially fall within the scope of the regulation and you would need to do your due diligence.
The EU Guidance document indicates that if the chemical structure of a compound has been changed as a result of research and development, the compound is not considered to be naturally occurring and therefore does not fall within the scope of Regulation (EU) No 511/2014.
Similarly, synthetically produced compounds are not within its scope.
Regulation (EU) No 511/2014 does not apply to sequence information obtained from publicly accessible databases.
The Guidance Document says that if researchers generate sequences from material, it is possible that this use or publication of such data might be covered by conditions set in the mutually agreed terms. These contractual obligations should be respected and may include informing subsequent actors about any rights and obligations attached to the data and the further use of them.
Associated Traditional Knowledge
Traditional knowledge associated with “genetic resources” is defined by Regulation (EU) No 511/2014 as ‘traditional knowledge held by an indigenous or local community that is relevant for utilisation of the genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources’.
To be in scope of the regulation, this traditional knowledge must be related to the research on the genetic and/or biochemical composition of the material (i.e. “utilisation”) of a genetic resource and must be covered by benefit-sharing arrangements, i.e. in the mutually agreed terms.
Where the material comes from
Nagoya Protocol countries only
The country where the material originally came from is usually referred to as the “provider country”. Regulation (EU) No 511/2014 only applies if the material originally came from a country that was a Nagoya Protocol country at the time the material was obtained.
That means you need to find out:
- whether the country is a Nagoya Protocol country AND
- when it became a Nagoya Protocol country.
You can find this information under the country profile in the ABS Clearing House.
Caution! There are some non-Nagoya Protocol countries that also have laws on access and benefit-sharing! In this case, you still need to comply with their national laws, your national ABS permit and your benefit-sharing agreement but you do not have any additional compliance obligations in Germany according to Regulation (EU) No 511/2014.
National laws on access and benefit-sharing
The Nagoya Protocol only applies in places where countries make national laws. Material from areas beyond national jurisdiction are not Nagoya Protocol relevant, e.g. the high seas.
Regulation (EU) No 511/2014 only applies to you if:
- the country where the material comes from regulates access; AND
- the ABS rules apply to your material. It is possible that the law only applies to certain types of organisms or material collected in certain areas; AND
- the rules applied at the time the material was obtained.
You can find information about ABS “measures” in the ABS Clearing House.
Just because there are no laws listed in the ABS Clearing House does not mean that none exist. Unfortunately, the ABS Clearing House is not always complete or up to date.
What does the EU Guidance document say about where the material comes from?
It makes no difference if you collect the material in the field or get it indirectly, i.e. through an intermediary such as a collection, a company or a collaboration partner. Regulation (EU) No 511/2014 may still apply.
Once alien and invasive species or biocontrol organisms are self-sustaining in the wild in an EU country, they are considered to come originally from that EU country, even though they are not native there.
According to the EU Guidance Document, the provider country of the human 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.
What to do if it is not possible to identify the provider country?
Regulation (EU) No 511/2014 does not prohibit the use of material when the origin 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 EU law). If you find out that there are access measures in the country where the material came from and you need to comply with these, 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.
When was the material obtained?
Regulation (EU) No 511/2014 only applies to material that was originally obtained from the provider country on or after 12 October 2014. It doesn’t matter if the research starts at a later point in time.
Some countries had legally binding rules on ABS in place BEFORE the Nagoya Protocol existed. Just because the material was obtained before 2014, it does not mean that access and benefit-sharing obligations did not apply that material (even if the EU law does not apply).
What to do if it is not possible to find out the time of access?
Regulation (EU) No 511/2014 does not prohibit the use of material when the 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 EU law). If you find out that there are access measures in the country where the material came from and you need to comply with these, 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.
The research
Research in Germany
In order for you to have compliance obligations in Germany, the research also has to take place in Germany. Collaboration partners in other European Union member States have the same obligations – that’s because they stem from EU law.
Collaboration partners outside of the European Union, e.g. in the USA, do not have any obligations under Regulation EU (No) 511/2014.
Collaborators from foreign countries who come to Germany to do some or all of their research are also required to comply with Regulation (EU) No 511/2014.
Utilisation
To have compliance obligations, your research has to be “utilisation”. Utilisation means research, including basic and non-commercial research, and development on the genetic AND/OR biochemical composition of the material, including through the application of biotechnology. This includes non-commercial and basic research.
What does the EU Guidance document say about utilisation?
Development of a testing tool or reference material
The development of a testing tool or reference material where it involves research on the genetic and/or biochemical composition of a genetic resource is utilisation.
Use of testing tools and reference material
Use of material as a testing platform or reference tool is not considered to be utilisation. Examples referred to in the EU Guidance Document include:
- Laboratory animals used to test their reaction to medical products
- Vectors used to introduce foreign material (e.g. pathogens or genes) into host organisms
- Hosts used for cloning purposes, e.g. E. Coli.
- Pathogens used for testing biocontrol and biostimulant agents
- Rats used in toxicological studies aimed at testing synthesised compounds
- Use of organisms as biofactories, e.g. cells used for vaccine manufacturing
- Bacteria used for testing the effectiveness of compounds that are candidates for new antibiotics
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) 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 be utilization.
The exact transition from phylogeny/taxonomy to utilization must be handled on a case-by-case basis.
The identification and classification of organisms is not considered to be a form of utilization as long as the research does not investigate the genetic and/or biochemical composition of the organism.
Taxonomic identification of biological or genetic material, by morphological or molecular analysis, including through use of DNA sequencing, is not considered to be utilisation as long as it does not involve the discovery of specific genetic and/or biochemical functionality. There is no difference whether the taxonomic identification points to a previously named entity or a previously undescribed species.
If the description or characterisation of a “genetic resource” is combined with research that is focused on discovery or examination of specific genetic and/or biochemical traits, this would qualify as utilisation.
Breeding animals or plants for production or to maintain a sustainable population does not count as utilization.
Taking material from a commercial source, e.g. a breeder, and using it for research on the genetic and/or biochemical composition of the material amounts to a “change of intent” and could fall within the scope of Regulation (EU) No 511/2014.
How might material provided by a commercial breeder fall within the scope of the regulation?
- The country where the commercial breeder is located may regulate access, 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 obligations that continue to apply to the subsequent use of this material for research.
Simply storing and/or displaying material, e.g. in a natural history museum, does not constitute utilization.
Collection of samples is not considered to be utilization.
Simply planting and harvesting of seeds or other reproductive material is not utilization.
Isolation of a new biochemical compound is utilisation.
Genetic modification of living organisms is utilisation.
Supply and processing of raw materials, e.g. to be incorporated into a product, is not utilisation.
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.
According to the EU Guidance Document, a newly created strain remains within the scope of Regulation (EU) No 511/2014 until it becomes publicly available to laboratories/researchers.
Some types of activities referred to above may not be considered “utilisation” within the meaning of Regulation ( EU) No 511/2014 BUT the national access and benefit-sharing laws of the provider country may treat these activities as being ABS relevant.
Checklist
Use this checklist to work out if you have compliance obligations under Regulation (EU) No 511/2014.
Does the research take place in Germany?
Was the material originally obtained from the provider country ON or AFTER 12 October 2014?
Was the country where the material originally comes from a Nagoya Protocol country at the time of access?
Did the provider country have national laws dealing with access to their “genetic resources” at the time of access?
Are you doing research on material that contains genes OR are you doing research on derivatives, i.e. products of gene expression like proteins, metabolites etc. AND there is sufficient continuity between the genetic material and the derivative?
Is your research utilisation, i.e. research, including basic and non-commercial research, and development on the genetic and/or biochemical composition of the material, including through the application of biotechnology, that leads to new knowledge?
If you answered yes to ALL the questions, you have compliance obligations under Regulation (EU) No 511/2014.
Other useful resources
Tools:
Kiel University has also developed a useful checklist for working out whether you fall within the scope of the EU Regulation.
The Dutch National Focal Point provides a help tool on its website to help researchers determine if their activities are in scope of the EU ABS Regulation.
Websites:
You can find a number of useful resources on the EU Commission’s Nagoya Protocol website.
The BfN page on legal questions covers a range of topics including questions about compliance obligations (in German).
Guidance Document:
The EU Guidance Document can help you to understand its scope.
