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 or Australia. 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.

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?

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.