Questions with links to answers
General information about the Nagoya Protocol and the ABS Regulation
- What is the Nagoya Protocol?
- What does Access and Benefit-Sharing (ABS) mean?
- Are there sector-specific rules for ABS?
- What is ABSCH (the Access and Benefit-Sharing Clearing-House)?
Implementation of the Nagoya Protocol and the ABS Regulation in Sweden and the EU
- How is the Nagoya Protocol implemented in Sweden and in the EU?
- Is access to genetic resources and associated traditional knowledge regulated in the EU and Sweden?
- Is the use of genetic resources and associated traditional knowledge regulated in the EU and Sweden?
Access to genetic resources outside the EU
- How does access to genetic resources and associated traditional knowledge work outside the EU?
- What does it mean that a country must give its Prior Informed Consent (PIC)?
- What are Mutually Agreed Terms (MAT)?
- How can I find information on the access legislation in other countries that are parties to the Nagoya Protocol?
The utilisation of genetic resources and traditional knowledge associated with genetic resources
- What is a genetic resource?
- What is traditional knowledge associated with genetic resources?
- What does the utilisation of genetic resources mean?
- What users and what genetic resources and associated traditional knowledge are in scope?
The user’s obligations
- What does fulfilling due diligence obligations mean?
- What do I need to do to meet the due diligence requirements?
- How should I declare due diligence?
- What should I, as a user, do if there is not enough information or if there are uncertainties about whether the access or the use is legal?
- For how long do information and documents on the access and equal distribution/ABS need to be stored and saved?
- What are users’ obligations as regards to submitting due diligence declarations?
- Who processes declarations of due diligence?
- What sanctions are available to deal with contraventions?
International certificate of compliance
- What is an Internationally Recognized Certified of Compliance (IRCC)?
Registered collections
- What is a registered collection?
- What are the requirements to register a collection?
- How do you register a collection?
- What are the advantages of registering a collection?
- How is it ensured that a registered collection is compliant with the requirements?
Best practice
- What does best practice mean?
- How do you obtain recognition of best practice?
- What are the advantages of best practice?
Science and research
- As a researcher, what do I need to think about?
Who does what?
- What is the role of the Swedish Environmental Protection Agency?
Answers
General information about the Nagoya Protocol and the ABS Regulation
1. What is the Nagoya Protocol?
The Nagoya Protocol is a binding agreement that regulates access to genetic resources and associated traditional knowledge and the fair and equitable sharing of benefits that accrue from the utilisation of these are. The protocol, which came into effect on 12 October 2014, is a key part of international work on nature and environmental protection.
2. What does Access and Benefit-Sharing (ABS) mean?
Access and Benefit-Sharing (ABS) means access to genetic resources and associated traditional knowledge and the fair and equitable sharing of benefits that accrue from their uutilisation. This is the third objective of the Convention on Biological Diversity.
ABS is a tool by which to ensure demonstrated consideration for the value of biological diversity in research and the development of new products and, by assigning financial value to genetic resources, to give a financial incentive to the preservation and sustainable use of nature.
The principles of ABS under the Convention on Biological Diversity, developed and clarified in the Nagoya Protocol, entail that access to genetic resources and associated traditional knowledge is regulated in the country in which the resource/the knowledge exists, given the country’s sovereign rights. Countries that are parties to the Nagoya Protocol must create conditions that will facilitate access to genetic resources and associated traditional knowledge for users. At the same time, they are entitled to demand that there be prior informed consent and an agreement that assures the fair and equitable distribution of benefits resulting from the utilisation of these resources and knowledge.
3. Are there sector-specific rules for ABS?
Over and above the ABS-related rules of the Convention on Biological Diversity and the Nagoya Protocol there may be sector-specific rules that are superior to the Nagoya Protocol.
Access to and use of genetic resources in food and agriculture may fall under specialized rules if they are affected by the plant genetic treaty (ITPGRFA). More information on the plant genetic treaty can be found below.
The influenza virus may be regulated by the Pandemic Influenza Preparedness Framework (PIP), which is a framework that regulates the spread of the influenza virus. You can read more about PIP on the website of the World Health Organization (WHO) (in English only).
These international ABS-related rules apply provided they do not conflict with the purposes of the Convention on Biological Diversity and the Nagoya Protocol.
4. What is ABSCH (the Access and Benefit-Sharing Clearing-House)?
The ABS Clearing-House is an international Web-based platform created to support the implementation of the Nagoya Protocol by sharing information about ABS, promoting openness and the rule of law, and bringing holders of genetic resources and/or associated traditional knowledge and users together.
The ABS Clearing-House contributes information pertaining to:
- ABS focal points, competent authorities and checkpoints
- National ABS legislation
- Published ABS permit
- Links to websites and databases
You can find the ABS Clearing-House here. It is administrated by the Secretariat of the Convention on Biological Diversity.
Implementation of the Nagoya Protocol and the ABS Regulation in the EU and Sweden
1. How is the Nagoya Protocol implemented in Sweden and in the EU?
In the EU, the Nagoya Protocol is implemented through the European Parliament and Regulation (EU) No. 511/2014 on measures for the users’ compliance in the Nagoya Protocol on the access to and the fair and equitable distribution of benefits arising from the utilisation of genetic resources in the Union, also called the EU ABS Regulation.
A supplementary Swedish regulation on the use of genetic resources and traditional knowledge about such resources applies as of 1 October 2016 (SFS 2016:858).
2. Is access to genetic resources and associated traditional knowledge regulated in the EU and Sweden?
The rules that apply to ABS in the Convention on Biological Diversity and the Nagoya Protocol give the parties an opportunity to enact legislation on the access to and use of genetic resources and associated traditional knowledge in their country.
The EU ABS Regulation is intended to ensure that the access to and use of genetic resources and associated traditional knowledge in the EU takes place in accordance with the ABS provisions in the access country from which the resource/the knowledge originates and that any profit that results from its use is allocated reasonably and fairly.
Unlike the case in certain other EU countries, Sweden has no national legislation governing access to genetic resources and/or associated traditional knowledge. This means that as a user, you do not need consents and agreements in accordance with the Nagoya Protocol in order to use Swedish genetic resources and associated traditional knowledge.
For a few species, however, there is legislation that restricts or forbids all use. Species that are protected may not be collected (Species Protection Ordinance SFS 2007:845). Dispensations or permits in accordance with the Environmental Code (SFS 1998:808) from the county administrative board or in certain cases the municipality may be required if the resource exists in a nature conservation area or in a national park.
3. Is the use of genetic resources and associated traditional knowledge regulated in the EU and Sweden?
In the EU and Sweden, the use of genetic resources and associated traditional knowledge involves special requirements and obligations (for example, declaring due diligence).
Access to genetic resources and associated traditional knowledge outside the EU
1. How does access to genetic resources and associated traditional knowledge work outside the EU?
Access to genetic resources and associated traditional knowledge is regulated by national legislation as a result of countries’ sovereign rights over their own genetic resources and associated traditional knowledge.
The ABS regulations given in the Convention for Biological Diversity and in the Nagoya Protocol state that countries that hold genetic resources and associated transitional knowledge have the power to:
- Grant access to the resource/traditional knowledge only after they have given their Prior Informed Consent (PIC).
- Grant access after the establishment of Mutually Agreed Terms (MAT).
Consequently, countries that hold genetic resources and associated traditional knowledge may grant access to conditional on the requirement that there must be an agreement whereby both parties will benefit from the use of the resource/the knowledge.
Access to traditional knowledge associated with genetic resources in the possession of local and indigenous peoples is thus in scope of the requirement of Prior Informed Consent and Mutually Agreed Terms. Customary rights and protocols in local communities may also need to be taken into account.
2. What does it mean that a country must give its Prior Informed Consent (PIC)?
A precondition of access to genetic resources and associated traditional knowledge in accordance with the Nagoya Protocol and the EU ABS Regulation is that the provider country must give its prior informed consent stating precisely how the access is to take place.
3. What are Mutually Agreed Terms (MAT)?
A precondition of access to genetic resources and associated traditional knowledge in accordance with the Nagoya Protocol and the EU ABS Regulation is that there must be an agreement on mutually agreed conditions for the utilisation of the resource and/or the knowledge and how the benefit is to be fairly and equitably shared between the various parties.
4. How can I find information on the access legislation in other countries that are parties to the Nagoya Protocol?
Information on national rules governing access and fair distribution of benefit, as well as on competent authorities, can be found in the ABS Clearing-House. The ABS Clearing-House is an international Web-based platform created to support the implementation of the Nagoya Protocol by sharing information about ABS, promoting openness and the rule of law, and bringing holders of genetic resources and/or associated traditional knowledge and users together.
The ABS Clearing-House contributes information pertaining to:
- ABS focal points, competent authorities and checkpoints
- National ABS rules
- Published ABS permits
- Links to websites and databases
The use of genetic resources and associated traditional knowledge
1. What is a genetic resource?
A genetic resource is defined in the EU ABS Regulation as genetic material of actual or potential value. Genetic material can be organic material from plants, animals, microorganisms or other organic material that contains functional units of heredity. Different types of biochemical materials that are derived from genetic material (or example, through genetic expression or metabolization) can also be classified as genetic material. Examples of derivatives include proteins, lipids, enzymes, RNA and other organic substances, such as flavonoids, essential oils and plant resin.
The EU ABS Regulation and the Nagoya Protocol do not encompass the human genome or material covered by ABS rules in other international agreements. For example, the influenza virus and plants covered by the plant genetic agreement (ITPGRFA) are not included.
2. What is traditional knowledge associated with genetic resources?
Traditional knowledge associated with genetic resources means traditional knowledge possessed by indigenous peoples or local communities, is relevant for the use of the genetic resource and is described in the mutually agreed terms (MAT).
3. What does the utilisation of genetic resources mean?
The Nagoya Protocol defines the utilisation of a genetic resource as performing “research and development of genetic or biochemical composition of genetic resources, including through the application of biotechnology” (Article 2).
Biotechnology is defined in Article 2 of the Convention on Biological Diversity as “every use of technology that employs biological systems, living organisms or derivatives thereof, to create or modify products or processes for a specific use”. The Nagoya Protocol defines derivative as a “naturally occurring biochemical composition that is a result of the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of genetic material”. Examples of derivatives include proteins, lipids, enzymes, RNA and other organic substances, such as flavonoids, essential oils and resin.
4. What users and what genetic resources and associated traditional knowledge are in scope?
Which users are in scope?
A user of a genetic resource is a physical or legal person who uses a genetic resource and/or associated traditional knowledge in connection with research.
The key factor determining whether the utilisation is covered by the EU ABS Regulation and the Nagoya Protocol is whether the physical or legal person conducts research or product development in the EU on the genetic or biochemical composition of genetic resources. The use of traditional knowledge associated with genetic resources is covered when the holder of the said resources has its own access rules.
The application does not differ for different types of legal persons, organizations of different sizes or the purpose of the research or product development, regardless of whether it be a matter of basic research, applied research or commercial research and development.
Physical or legal persons that only store, forward or sell genetic resources and/or associated traditional knowledge without conducting research or product development are not considered users.
Material scope:
A genetic resource is defined in the Nagoya Protocol and the EU ABS Regulation as “genetic material of actual or potential value”, and genetic material may in turn be organic material from plants, animals, microorganisms or other organic material that contains genes.
The protocol and the regulations do not encompass genetic resources that are only found in the human genome and certain other sectoral areas that are covered by special ABS rules.
Traditional knowledge associated with genetic resources means traditional knowledge possessed by indigenous peoples or local communities, is relevant for the use of the genetic resource and is described in the mutually agreed terms (MAT).
Geographical scope:
Genetic resources and associated traditional knowledge are in scope only if they originate in a country that is a signatory to the Nagoya Protocol and that has ABS legislation. Information of what countries are parties to the Nagoya Protocol and have access legislation can be found in the ABS Clearing-House. This legislation must also apply to the particular genetic resource and/or associated traditional knowledge that has been obtained.
The Regulation and the Nagoya Protocol do not cover genetic resources and/or associated traditional knowledge that falls outside a country’s sovereign rights. This means that material from international waters, deep sea bottoms and areas covered by the Antarctic Treaty are not in scope.
The use of genetic resources and/or associated traditional knowledge is only in scope ofthe EU ABS Regulation if it occurs in an EU country.
Temporal scope:
The regulation encompasses only genetic resources and associated traditional knowledge that has been accessed after 12 October 2014 (when the Nagoya Protocol came into effect). If the access occurred earlier, the regulation does not apply – this applies also in cases where the use started after that date. Here it is important to not that there may be national legislation that applied before 12 October 2014.
The user’s obligations
1. What does fulfilling due diligence obligations mean?
Showing due diligence entails making a commitment to proceed with caution and care. The user must show due diligence in the EU ABS Regulation by ensuring that the user has accessed the resource and the knowledge in accordance with the applicable legislation that exists in the country from which the resource/knowledge has been obtained. Also, the benefit that arises from this use is to be shared fairly and equitably with the provider country, affected indigenous peoples or local communities in accordance with mutual agreed terms.
2. What do I need to do to meet the due diligence requirements?
To meet the due diligence requirements users must seek, store and transfer to subsequent users:
- An Internationally Recognized Certified of Compliance (IRCC)
- Information on the content of mutually agreed terms
If there is no internationally recognized certificate, the following information must be obtained, stored and transferred to subsequent users:
- Date and place for access to the genetic resource and/or the associated traditional knowledge
- Description of the resource/the knowledge
- Source from which the resource/the knowledge was obtained directly and subsequent users
- The occurrence or absence of rights or obligations concerning ABS, including subsequent application and commercialization
- Permission for access in applicable cases
- Mutually Agreed Terms in applicable cases
3. How do I declare due diligence?
Declare due diligence to the relevant authority (Environment Protection Agency for users in Sweden) via the DECLARE tool that you will find below.
4. How should I, as a user, proceed if sufficient information does not exist or if there is uncertainty concerning whether the access or utilisation is legal?
Where there is no information available or if uncertainties arise about the legislation that affects the access to and utilisation of genetic resources and associated traditional knowledge, the user must establish mutually agreed terms. If this is not possible, the utilisation must cease (Article 4.5 of the EU ABS Regulation).
5. For how long do information and documents on ABS need to be stored?
Information and documentation on ABS must be kept for 20 years after the use has ceased.
6. What are users’ obligations as regards to submitting due diligence declarations?
You must show that you abide by the access legislation of the country in question. You must show this by obtaining prior informed consent (PIC) and establishing mutually agreed terms (MAT) and by declaring due diligence in accordance with the ABS Regulation.
You must declare as of the time the first payment of research funds, or equivalent funding, is made to a point not later than the conclusion of the research. A second declaration must also be made in conjunction with the approval or product launch on the market.
7. Who processes declarations of demonstrated due diligence?
The Swedish Environmental Protection Agency is the competent authority and is tasked with conducting supervision of the users’ declaration in accordance with C. 26 of the Environmental Code (1998:808) and Ch. 2, Section 9 a of the Environmental Supervision Ordinance (2011:13).
8. What sanctions are available to deal with contraventions?
Provisions on environmental sanctions fines can be found in Ch. 2, Sections 4-5 of the Environmental Sanctions Fines Ordinance (2012:259). If a declaration is not submitted within the prescribed time period, an environmental sanctions fine of SEK 5,000 must be paid.
Provisions on penalties and forfeitures can be found in Ch. 29 of the Environmental Code (1998:808). A user who fails to meet his or her obligations by not complying with mutually agreed terms or handling information in the proper manner may be required to pay fines or may be sentenced with imprisonment of up to two years (Ch. 29, Section 8 of the Environmental Code). Genetic resources that have been the subject of criminal acts may be declared forfeited (Ch. 29, Section 12 of the Environmental Code).
The supervisory authority (the Swedish Environmental Protection Agency) must ensure that the applicable rules are complied with and must take such measures as are necessary to ensure that the users comply with the rules. This can be done by declaring injunctions or prohibitions that may be associated with fines (Ch. 26 of the Environmental Code).
Internationally Recognized Certificate of Compliance
1. What is an Internationally Recognized Certificate of Compliance (IRCC)?
An internationally recognized certificate of compliance is a permit or an equivalent document that has been issued in conjunction with the access as a certificate showing that the genetic resource and/or associated traditional knowledge to which the certificate applies has been obtained in accordance with prior informed consent and mutually agreed terms. The authority that issues the certificate should publish it on the ABS-Clearing house.
Registered collections
1. What is a registered collection?
A certificate that a collection (for example museums and botanical gardens) meets certain conditions – a so-called registered collection – has been introduced in the EU. Persons who use genetic resources from these collections are considered to have fulfilled due diligence obligations and therefore need not seek any permits of their own to utilize these resources.
2. What are the requirements to register a collection?
In order for a collection or part thereof to be registered, it must fulfil the criteria specified in Article 5 of the EU ABS Regulation (EU Regulation No. 511/2014). The information requirement for application can be found in Appendix 1 to the EU Implementation Regulation (EU Regulation No. 2015/1866).
3. How does the registration of a collection proceed?
A collection wishing to be registered is welcome to contact the registrar of the Swedish Environmental Protection Agency
4. What are the advantages of registering a collection?
The advantages of registering a collection are that users need not obtain his or her own certificate and permit when the registered collection’s genetic resources are used.
5. How is it verified that a registered collection remains compliant with the requirements?
The Swedish Environmental Protection Agency must conduct regular inspections of the registered collections.
Best practice
1. What does best practice mean?
“Best practice” in Article 8 of the EU ABS Regulation means a combination of EU-recognized procedures, tools and mechanisms developed by organizations of users or other affected parties to more easily fulfil and declare due diligence.
Best practice can also be recognized internationally in accordance with Article 20 of the Nagoya Protocol.
2. How do you obtain recognition of best practice?
A best practice must be recognized by the European Commission and an application must be submitted containing the information listed in Annex IV to Article 8 of the EU Implementation Regulation (EU 2015/1866).
The European Commission administrates a Web-based register in which recognized best practices are published.
3. What are the advantages of best practice?
The Swedish Environmental Protection Agency takes the use of best practice into account as regards the requirement to perform due diligence as this entails a reduced risk.
Science and research
1. As a researcher, what do I need to think about?
Recipients of research funding relating to the use of genetic resources or associated traditional knowledge must declare due diligence in conjunction with the carrying out of the research involving the resource/knowledge, between the time the research funding is first paid out and the completion of the project.
Research funding is defined as some form of financial contribution intended to fund research, regardless of whether it is from a commercial or non-commercial source.
A second declaration of due diligence is submitted at the final stage of the development of a product – for example, in conjunction with product approval or the launching of the product in the market. You can read about how these declarations are to be done and submit the declaration via the DECLARE data submission tool.
Several users can submit a joint declaration if they perform joint research and receive research funding from the same source.
Who does what?
1. What is the role of the Swedish Environmental Protection Agency?
The Swedish Environmental Protection Agency is Sweden’s only competent authority for the Nagoya Protocol and the EU ABS Regulation. This implies a responsibility to examine and inspect users’ due diligence. The Swedish Environmental Protection Agency must also verify applications for registration by collections and must conduct regular inspections of the same. This role also includes providing advice and guidance in the use of genetic resources and associated traditional knowledge.