The Nagoya Protocol on Access and Benefit-sharing

Both the Nagoya Protocol and the EU-regulations on ABS (access and benefit sharing) govern access to genetic resources and the fair and equitable sharing of benefits arising from their utilization .

The Nagoya Protocol

The Nagoya Protocol is an international agreement which provides a transparent legal framework for the effective implementation of one of the three objectives of the Convention on Biodiversity (CBD): the fair and equitable sharing of benefits arising from the utilization of genetic resources.
The Protocol was adopted on 29 October 2010 in Nagoya, Japan and entered into force on 12 October 2014. ABS is about ensuring benefit sharing when utilizing genetic resources or traditional knowledge associated with the genetic resources. The access and benefit sharing consists of obtaining prior informed consent (PIC) when utilizing the genetic resources and establishing mutually agreed terms (MAT) between user and provider country. 

The Nagoya-protocol consists of 3 elements: 

1. Access to the genetic resources: The protocol reaffirms the sovereign rights of States over their natural resources. Danish companies and scientists must comply with the access-rules of the provider country when genetic resources is accessed. If the provider country has ratified the Nagoya Protocol, the companies and scientists must comply with the access-rules which can be found on the ABS-Clearing House (ABS-CH). 
2. Benefit-sharing when utilizing genetic resources: Benefit-sharing must be ensured by rules, which are established by the providing countries. Benefit-sharing can be monetary and non-monetary, such as sharing of research and development results, collaboration, capacity-building. A list of benefit-sharing elements can be found in the annex of the Nagoya-protocol. 
3. Compliance rules: The European Union established compliance-rules on the Nagoya Protocol in 2014. When genetic resources are accessed in other countries, the company or scientist must be able to show compliance with ABS-rules in the provider country. More information can be found in the EU Regulation no. 511/2014 and the Implementing Regulation no. 2015/1866.

The EU Regulation on ABS

The EU Regulation no. 511/2014 regulates compliance measures for users, access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. The Implementing Regulation contains No. 2015/1866 measures on specific aspects, as provided for in the EU ABS Regulation, in particular registered collections, best practices and monitoring of user compliance.

With regard to the monitoring of user compliance, a web-based application (DECLARE) was created to allow users' submission of due diligence declarations online. The manual for users of DECLARE provides an explanation on its use.
The Danish Environmental Agency is the competent authority in Denmark. Subsmissions of due diligence mustbe processed by the Danish EPA. 

Genetic resources and definitions

What is in scope?

The utilization of genetic resources and associated traditional knowledge is in scope of the Nagoya Protocol and the ABS-regulations.  
Genetic resources that are out of scope of the Nagoya Protocol are human genome, plant genetic material included on Annex 1 of the ITPGRFA, pendemic influenza virus (PIP) and genetic material collected from areas beyond national jurisdiction.  

What are genetic resources?

Genetic material means any material of plant, animal, microbial or other origin containing functional units of heredity while genetic resources refers to genetic material of actual or potential value.
Examples of genetic resources can be entire or parts of wild and cultivated plants, animals, trees, fungi and microorganisms.  

What is traditional knowledge associated with genetic resources?

Traditional knowledge on how genetic resources are used is also in scope of the Nagoya Protocol. Traditional knowledge held by indigenous and local communities could provide important lead information for the scientific discovery of interesting genetic or biochemical properties of genetic resources.

What is a collection? 

A collection of genetic material is in scope of the ABS-regulation. With collection is meant a set of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities. Examples of collections are botanical gardens, museums or private collectors/companies. 

Users and utilization of genetic resources

Are you user of genetic resources and traditional knowledge? 

Many products contain genetic resources. Before a products reaches the consumers, a chain of companies and scientists developed the products by utilizing genetic resources. This is the case for several pharmaceuticals, cosmetics, enzymes and food products. The users is a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources. Owners or holders of collections of genetic resourcs are also users. 

When is an activicy in scope of the ABS-regulation? 

Research and development in a genetic resource originating from a country with access-rules and ratified as a party to the Nagoya-protocol is in scope of the EU-regulation. Also the genetic resources must be accessed when the protocol was put into force the 12. october 2014 or later. 

When a genetic resources is utilized for research and development, the following conditions must be met before an activity is in scope of the EU-regulation: 

• The provider country has ratified as party to the Nagoya Protocol. 
• The provider country has established access-rules on acquisition of genetic resources
• The genetic resources are accessed 12. october 2014 or later. 

 If the conditions above apply, it is important to determine whether a genetic resource is covered by the EU regulation on ABS. The genetic resource or associated traditional knowledge will be in scope of the EU regulation if the genetic resource is utilized for the development of a product, for research or for the purpose of storing the genetic material in a collection (e.g. museums, botanical gardens or private collections). 

When are you not a user of genetic resources?

Trade and exchange of genetic resources as commodities (such as agricultural, fisheries or forestry products — whether for direct consumption or as ingredients, e.g. in food and drink products) fall outside the scope of the EU Regulation. The trade, use or procesing of e.g. Aloe vera, Shea or other known ingredients in the preparation of cosmetics is not in scope of the EU regulation, when it doesn't include new research or product development. 

How to comply with the legislation on genetic resources as user?

If you already use or consider accessing genetic resources or use associated traditional knowledge from other countries, you should inform about your obligations. The same applies when you collect genetic material for a collection with origin in other countries. 

The Danish Environmental Protection Agency is the competent national authority on ABS

The Danish EPA is the competent national authority on the EU regulation on ABS in Denmark. The EPA carries out checks on user compliance on utilization and benefit sharing of genetic ressources. 

More information on ABS

International agreement and regulation on ABS

The Nagoya Protocol on Access and Benefit Sharing
More information on The Nagoya Protocol
Parties of The Nagoya Protocol
The ABS-Clearing House

EU regulation on Access and Benefit Sharing No. 511/2014
Implementing regulation No. 2015/1866 
Annex to the Implementing Regulation (request for inclusion in the register of collections)

National legislation on ABS 

The Danish parliament adopted legislation on benefit sharing and utilization of genetic resources the 23 December 2012. The legislation entered into force the 12 October 2014.
The Danish order on competent national authority and punishment for violation of the EU regulation and Danish legislation entered into force the 15 July 2017. 

Lov om udbyttedeling ved anvendelse af genetiske ressourcer (Danish)

Bekendtgørelse om ansvarlig myndighed for administration af lov om udbyttedeling ved anvendelse af genetiske ressourcer og straf for overtrædelse(Danish)