The Nagoya Protocol and the EU ABS Regulation

General

Access and benefit-sharing (ABS) is a principle defined in both the Convention on Biological Diversity (CBD) and the Nagoya Protocol. The principle aims to create incentives for the protection and sustainable use of biological diversity. The purpose of ABS is to ensure a reasonable and fair distribution of the benefits that arise from the use of genetic resources and traditional knowledge.

The Nagoya Protocol regulates how genetic resources are acquired and used in research and development, and how profits and knowledge gained from such use are to be distributed. The Nagoya Protocol entered into force on 12 October 2014 and provides a legal framework for the fair distribution of benefits arising from the use of genetic resources. The aim is to create greater legal certainty for both the country that provides the resources and their users.

EU Regulation 511/2014 (the ABS Regulation) has been in force in Sweden since 12 October 2015. In short, this regulation provides that users of genetic resources must show that they comply with the legislation of the providing country regarding genetic resources and associated traditional knowledge. Users must also document this in a way that can be presented to the Swedish Environmental Protection Agency (Naturvårdsverket), the supervisory authority in Sweden, for checking compliance with current rules.

What is a genetic resource?

The Convention on Biological Diversity (CBD) defines genetic resources as “genetic material of actual or potential value” and “any material of plant, animal, microbial or other origin containing functional units of heredity.”

Genetic resources can thus be plants, animals or parts of them such as seeds, spores, plant parts, eggs, sperm or yeast cells, viruses and bacteria. They can, for example, be used in the development of pharmaceuticals and cosmetics or be used in basic research in, for example, ecology and biomedicine. Consequently, it is not whether the research is commercial or non-commercial that determines if the material is a genetic resource or not, but whether the material has or may have a value.

What is traditional knowledge?

Traditional knowledge can typically be the knowledge that an indigenous population or a local community with a traditional lifestyle has about how a specific resource can be used. Such traditional knowledge of the properties of a particular resource can be an important clue to new scientific discoveries.

National legislation differs in the definition of what is traditional knowledge. If, as a user, you are unsure whether your research includes traditional knowledge, it is important to contact the country from which the genetic resource and associated traditional knowledge are obtained for guidance.

What do researchers at SLU need to do?

If you intend to conduct research that involves a genetic resource and/or traditional knowledge, you need to find out what rules apply in the country where the resource is located. You can do this by using the Access and Benefit-Sharing Clearing-House (ABSCH), a website set up by the CBD Secretariat. Here, you will find information about which countries are parties to the Nagoya Protocol, national focal points, competent national authorities, national legislation and whether or not a country requires ABS. If you cooperate with any local actor from the country in question, you can also ask them for guidance and help.

Even countries that have not signed and implemented the Nagoya Protocol may have national legislation governing access to genetic resources and ABS. The key to good regulatory compliance is to familiarise yourself with and understand the ABS process in the country that provides the resource.

What help is available for SLU staff?

For support with legal aspects of the Nagoya protocol and ABS-issues contact nagoya@slu.se