The Nagoya Protocol and the EU-ABS regulation

The ABS Regulation is complemented by the European Commission Implementing Regulation (EU) 2015/1866 that lays down detailed rules concerning the implementation of some articles of the ABS Regulation. In Sweden, there is complementary legislation including provisions of penalties for non-compliance of the ABS Regulation and a declaration obligation for the users of traditional knowledge that is acquired separately from a genetic resource.

What is meant by genetic resources?

In the CBD and the ABS Regulation, genetic resources are defined as “genetic material of actual or potential value.” Genetic material means “any material of plant, animal, microbial, or other origin containing functional units of heredity.” The Nagoya Protocol defines derivatives as “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.” Derivatives such as RNA, proteins, lipids, and organic compounds such as flavonoids, essential oils, or resins from plants may also be genetic resources. The utilization of a derivative falls within the scope of the ABS Regulation if there is continuity between the derivative and the genetic resource from which the derivative was obtained.

The ABS Regulation does not apply to human genetic resources, genetic resources covered by specialized treaties (such as the International Plant Genetic Resources for Food and Agriculture ITPGRFA and the WHO’s Pandemic influenza preparedness Framework PIP) and genetic resources from areas beyond a country’s sovereign rights, for example, from international waters and areas covered by the Antarctic Treaty.

Digital sequence information on genetic resources (DSI), such as digital data on DNA and RNA sequences, is a controversial issue on the agenda of the CBD and its Nagoya Protocol. Sweden does not currently supervise the use of DSI.

What is meant by traditional knowledge associated with genetic resources?

Traditional knowledge associated with genetic resources means knowledge held by indigenous peoples or local communities that is relevant to the utilization of genetic resources. It comprises knowledge, innovations, and practices of communities with traditional lifestyles, which are relevant for the conservation and sustainable use of biodiversity. The legislation varies between countries regarding how traditional knowledge is defined and regulated. Typically, it is the bearer of knowledge who can authorize access to the knowledge and establish the conditions for its use and for benefit-sharing.

What is meant by utilization of genetic resources?

The Nagoya Protocol (art. 2) establishes that utilization of genetic resources means “to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology.” Biotechnology is defined in the same article as “any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”.

The ABS Regulation applies to both commercial and non-commercial research, basic research and applied research, as well as product development. The ABS Regulation does not apply to certain activities, such as the taxonomic identification of biological or genetic material by morphological or molecular analysis, the mere description of a genetic resource in phenotype-based research and the use of genetic resources as a testing tool (as opposed to the development of a testing tool that qualifies as utilization). If the characterization or description of a genetic resource is combined with research on that resource (i.e. discovery or examination of specific genetic and/or biochemical characteristics), the activities will qualify as utilization in terms of the Protocol and the ABS Regulation.

There is not a list of specific activities falling under the ABS Regulation’s definition of utilization, but the EU Guidance document includes examples of activities that are within and outside its scope. Look at sections 2.3.3, 2.3.4 and annex II of the document in order to determine if your research or product development qualifies as utilization according to the Regulation. Note, however, that this document is not legally binding and that some countries may have other interpretations.

Which obligations do I have as a user?

As a user of genetic resources and/or associated traditional knowledge in research or product development, you have a legal obligation to show due diligence. This entails ensuring that access to the resources and/or knowledge occurs in accordance with the legislation of the provider country and that the benefits are shared reasonably and fairly, following relevant laws and mutually agreed conditions where applicable.

These obligations apply to resources and knowledge accessed in a country that is party to the Nagoya Protocol from October 12, 2014, onwards. It does not matter whether the resource or knowledge was acquired on-site, received from collaboration partners, or indirectly obtained from intermediaries such as biobanks or museum collections. Genetic material collected in-situ (at the original location) before October 12, 2014, which you acquire from an ex-situ collection within the country of origin after that date, falls temporarily within the scope of the ABS Regulation.

Viewed as a duty to investigate, the obligation of due diligence requires you:

• To determine whether the genetic resource and your utilization fall within the scope of the ABS Regulation.
• To ascertain whether the provider country is a party to the Nagoya Protocol and if there is relevant access legislation in place. Information about the protocol parties, including competent authorities and pertinent national legislation, can be found on the ABS Clearing-House (ABSCH) –a platform for information exchange among the parties to the Protocol. Even if a country is not a party, it may have access rules that must be followed, irrespective of the Protocol and the ABS Regulation.
• Take contact with the competent authority (or the national focal point, if appropriate) in the provider country to inquire about relevant legislation, conditions for Prior Informed Consent (PIC), the requirement to establish mutually agreed terms (MAT), and any other requirements. If you are uncertain whether your research involves traditional knowledge according to the country’s definition, seek clarification from the competent authority.

You need to obtain all required permits and documents. The competent authority in the provider country may issue an Internationally Recognized Certificate of Compliance (IRCC) as proof of compliance. If you acquire genetic resources indirectly through an intermediary, verify that the intermediary obtained relevant permits and agreements at the time of accessing the genetic resource.

Keep relevant documents and information (such as email exchange with the competent authority) as they serve as evidence of due diligence. Information and documents must be retained for 20 years after the utilization period. Users are responsible for transferring these records to subsequent users of the resource or knowledge.

Notify the head of your department or the director of your center or institute if your research or product development falls under the ABS Regulation.

Even guest researchers and students who bring in and use foreign genetic resources or traditional knowledge in Sweden must comply with the requirements of the ABS Regulation.

Which documents and information are required?

Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) are commonly required, although these types of documents may have other names or be combined into one. Be aware that legislation and statutory requirements on access and benefit sharing vary between countries. Some countries may not have access legislation and/or may not require specific agreements or benefit-sharing measures.

When an agreement is needed, you should contact REIS as soon as possible. REIS facilitates contact with the university's lawyers for the purpose of revising the draft. The agreement has to be signed by the head of department, director of the center or other authorized person according to the university’s delegation rules.

In the case of indirect acquisition of genetic resources via an intermediary, you should obtain the documentation (PIC, MAT or equivalent document) that was received when access originally took place. It may be necessary to change PIC or/and MAT or to obtain a new one (or new ones) if the intended use is not covered or only partly covered by the original terms of the document/s.

According to the ABS Regulation, the user must seek, keep and transfer to subsequent users the Internationally-Recognized Certificate of Compliance (IRCC) as well as information on the content of the mutually agreed terms that is relevant for subsequent users.

If an IRCC is not available, the user shall seek, keep and transfer information and relevant documents on:

• the date and place of access of genetic resources or of traditional knowledge associated with genetic resources;
• the description of the resources or of the knowledge;
• the source from which the resources or the knowledge were directly obtained (as well as subsequent users of resources or knowledge);
• the presence or absence of rights and obligations relating to access and benefit-sharing (including rights and obligations regarding subsequent applications and commercialization);
• access permits, where applicable;
• mutually agreed terms (including benefit-sharing arrangements), where applicable

This information and documentation is also necessary to declare due diligence if there is no IRCC available.

When and how to declare due diligence?

Researchers, as users of genetic resources or traditional knowledge associated with genetic resources, must declare due diligence when they receive external funding (regardless of the funding agency being public or private) or develop a product. A declaration has to be submitted on the following occasions:

1. After the first instalment of research funding has been received or at the latest at the end of the project, or when the final report is submitted.
2. At the final stage of development of a product: at the time of authorization, at the time of placing a product in the market or when the result is sold or transferred to a natural or legal person.

Declarations are submitted via DECLARE (EU’s digital tool for this purpose) to the Swedish Environmental Protection Agency that is the competent authority in Sweden. There is only one official DECLARE account for the entire university that is managed by REIS, which assists researchers with declarations.

If you need to declare due diligence, you have to contact REIS and provide us with the information and documentation required for a declaration. You should inform us if there is information that needs to be kept confidential. Once the declaration is completed and approved, we register the provided documentation in the university's record keeping system.

If the utilization of the resource or knowledge is covered by the ABS Regulation but a declaration is not required (e.g. in the case funding comes from the university´s internal budgetary resources), you should still comply with due diligence requirements. Relevant information and documents should be sent to REIS for registration.

What happens if the rules are not followed?

The Swedish Environmental Protection Agency is the supervisory authority responsible for ensuring that users of genetic resources and/or associated traditional knowledge in Sweden comply with the ABS Regulation. During inspections and other compliance checks, the supervisory agency may require additional information and documentation as well as issue injunctions and prohibitions. If a user fails to meet compliance obligations by not following mutually agreed terms or not showing due diligence, the matter can be handed over to the police or- the prosecutor's office. Potential sanctions are fines or imprisonment of up to two years.

Outside the legal sphere, lack of compliance can have negative consequences for some aspects of the researcher’s work such as the ability to publish in certain journals, to participate in research collaborations, or to deposit the genetic material in some collections.

Support and guidance

If you consider that your research may fall within the scope of the Nagoya Protocol and the ABS Regulation, that a declaration of due diligence needs to be submitted or if you have questions, please contact the Office for Research, Engagement and Innovation Services for support (write to viviana.stechina@su.se).

The text in previous sections summarizes important information but it is not a complete account of the subject. You should look at the EU's guidance document and visit the Swedish Environmental Protection Agency's website for more detailed information and guidance. Watch also the agency’s films ”När du använder genetiska resurser” and ”När du hämtar genetiska resurser”.

As supervisory authority, the Swedish Environmental Protection Agency provides guidance to users in Sweden. You are welcome to pose questions via email, to nagoya@naturvardsverket.se.