About the bases of the Nagoya Protocol
+ Convention on Biological Diversity (CBD)
The Convention on Biological Diversity is an international treaty that has three main objectives: (1) the conservation of biological diversity, (2) its sustainable use and (3) the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. It was adopted in 1992 at the Earth Summit in Rio de Janeiro and knows 196 signatory states in 2018. The Nagoya Protocol is a protocol to the CBD.
+ Bonn guidelines
The Bonn Guidelines were voluntary rules on the access to genetic resources and the benefit sharing aiming at a harmonised implementation of that issue. It was elaborated by a working group established by the Conference of the Parties to the CBD. In 2002 the Earth Summit of Johannesburg mandated to set up a binding agreement based on the guidelines, which was to become the Nagoya Protocol. The Bonn Guidelines still serve as an easy-to-read document that explains the concept of the Nagoya Protocol.
About the Nagoya Protocol
+ Nagoya Protocol
The Nagoya Protocol is a binding international agreement adopted on 29 October 2010 in Nagoya, Japan, which entered into force on 12 October 2014. Its roots lie with the 1992 Convention on Biological Diversity. By February 2018, 105 states had ratified the protocol, including the European Union and Switzerland.
+ Genetic material and genetic resources
"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 (CBD Art. 2).
In the context of agriculture and horticulture, all seeds and seedling are concerned.
+ Provider country
Provider country is either the country that holds the genetic resource in its natural habitat (in-situ) or that holds it in a collection (ex-situ). An in-situ-country is also called “country of origin”.
Each signatory is free to pass over the control over its genetic resources to its citizens – partly or fully. Examples are in-situ-resources on private estates or in indigenous reserves and ex-situ-resources in gene banks of seed saving associations or research institutes. The legal system of the respective state applies.
+ Utilization of genetic resources
„Utilization of genetic resources” means to conduct research and development on the genetic material. The term includes traditional breeding methods, i.e. breeding without laboratory or genetic engineering.
+ Prior informed consent (PIC)
This is an important Nagoya principle:
It refers to the administrative permit given by the competent national authority or entitled person of a provider country to a user, prior to accessing genetic resources. “Informed” means that the prospective user must give reasons as to the purpose of the access. However, the term is also used in relation to the right of indigenous and local communities to take a free and informed choice on whether they wish to give access to genetic resources or associated traditional knowledge.
Each signatory state in turn is obliged to provide access to such permits in a transparent and reliable manner.
+ Benefit sharing
All benefits arising from the utilization of genetic resources as well as their commercialization have to be shared in a “fair and equitable” way with the provider country. This Nagoya principle applies to immediate benefits as well as benefits that reveal at a later time. Benefit sharing therefore is a clear incentive to protect biodiversity in-situ as well as to maintain ex-situ-resources.
What does “fair and equitable” mean? The Nagoya Protocol doesn’t give any definition; it merely states that benefit sharing shall be upon “mutually agreed terms”. Again, each signatory is obliged to set rules how such mutually agreed terms are to be achieved and how their realisation will be safeguarded.
Possible forms of benefit sharing are listed in the annex of the Nagoya Protocol. Examples are licence fees in case of commercialization as a monetary benefit or the sharing of research and development results as a non-monetary benefit.
+ Indigenous people and local communities
The rights of indigenous people and local communities – that vary from signatory state to signatory state – are protected by the Nagoya Protocol. Indigenous people and local communities have to be consulted for prior informed consent and they participate in the benefit sharing when it comes to genetic resources on their territories.
+ Access and Benefit-Sharing Clearing-House (ABSCH)
The Access and Benefit Sharing Clearing House (ABSCH) is an information platform on national laws, competent authorities and focal points for the Nagoya Protocol, located in Montreal. It informs (via website) about the state of implementation of each signatory and it holds the register of internationally recognized certificates of compliance (IRCC). An IRCC provides legal certainty about the prior informed consent and the terms of benefit sharing.
About the implementation in the EU and Switzerland
+ Due diligence
The main responsibility in terms of compliance with the Nagoya rules lies with the users. They have to act with reasonable and appropriate diligence to document transfer, use of genetic resources, and terms of benefit sharing. At the market entry of a new product from research and development, these documents must be reported to the national competent authorities. In Switzerland this is the Swiss Federal Office for the Environment. The retention period of information is ten years in Switzerland and 20 years in the EU, and starts when the product is withdrawn from market.
In regard to the prior informed consent and the benefit sharing, Switzerland and most EU countries leave it to the owner of a genetic resource, e.g. a community seed bank, to issue the documents and to agree on the terms of benefit sharing.
+ Best practices
In order to reach harmonisation in regard to the terms of transfer of genetic resources and to the modes of benefit sharing, best practices of material transfer agreements can be submitted for recognition to the European Commission or the Swiss Federal Office for the Environment resp.