The Nagoya Protocol on Access and Benefit-sharing

The Nagoya Protocol is based on every country’s sovereign rights to regulate access to their genetic resources. Danish companies and researchers, who acquire genetic resources from other countries who ratified the Nagoya Protocol must comply with the access regulation in country of origin.

When a country regulates access to its genetic resources and associated traditional knowledge access must be based on a prior informed consent (PIC) and mutual agreed terms (MAT) between Parties to the Nagoya Protocol. When a user has obtained PIC and MAT from the country of origin, the user has exercised due diligence – see “user obligations”.

List of countries and their status on ratification of the Nagoya Protocol (ABS CH).

Benefit sharing must be ensured through regulation adopted in the country of origin with access regulation. Benefit sharing can be monetary or non-monetary e.g. knowledge sharing, capacity building, transfer of technology or participation in product development.

A thorough list of possible elements is found in the annex of the Nagoya Protocol.

The EU implemented common regulation on compliance with the Nagoya Protocol in the member states in 2014 When Danish companies and researchers obtain genetic resources in a country with ABS access regulation, they must declare to the Danish authorities, that they comply with the country’s regulation.

For more information: EU ABS regulation no. 511/2014 and EU implementing regulation no. 2015/1866

Genetic resources, traditional knowledge associated with genetic resources and collections of genetic resources are covered by the Nagoya Protocol and the EU ABS regulation. Human genetic resources are not included.

Genetic material means any material of plant, animal, microbial or other origin containing functional units of heredity. Genetic resources means genetic material of actual or potential value.

Traditional knowledge associated with genetic resources means traditional knowledge held by indigenous or local communities that is relevant for the utilisation of genetic resources. Traditional knowledge can be described in the mutually agreed terms (MAT) applying to the utilisation of genetic resources.

A collection means a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities.

User means a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources for research and development.

The EU ABS regulations only apply to research and development in genetic resources in EU countries. It concerns genetic resources and traditional knowledge associated to genetic resources from countries Party to the Nagoya Protocol the genetic resources and traditional knowledge associated with genetic resources covers genetic resources accessed after the Nagoya Protocol entered into force on 12 October 2014 or later.

You are not considered a user in relation to the ABS regulation, if you supply and process relevant raw materials for subsequent incorporation in a product where the properties of the biochemical compound contained in the genetic resources are already known and therefore no research and development is carried out – such as, for example, supply and processing of Aloe Vera, Shea nut or butter, rose essential oils, etc. for further incorporation into cosmetics. If new products are developed or research is conducted in the products, the company or researcher must be aware of the access measures of the country of origin.

If you are a user or plan to access genetic resources or traditional knowledge associated with the genetic resources from other countries for research and development you must identify your obligations.  When collecting or accessing genetic resources from a collection, you also must ensure to comply with the ABS obligations.

The Danish EPA conducts checks with users of genetic resources for compliance with the EU ABS regulation.

In Denmark, the Danish EPA is the competent authority for the administration of the EU ABS regulations. According to the executive order Bekendtgørelse om ansvarlig myndighed for administrationen af lov om udbyttedeling ved anvendelse af genetiske ressourcer it conducts user checks in order to ensure compliance with the EU ABS regulation in Denmark.