Guidance

Utilizing genetic resources

Aloe-växt

Guidance on the utilization of genetic resources in research and product development.

The Nagoya Protocol and the EU Access and Benefit-Sharing (ABS) Regulation, No. 511/2014, apply both to commercial and non-commercial researchers.

Researchers conducting basic research and applied research on biological material and/or associated traditional knowledge shall comply with these regulations.

Target Group

Those who conduct research or product development on biological material (genetic resources), approve applications for research funding, work for public agencies involved in product approval, are custodians of collections of biological material.

Basic obligations - Steps to determine whether you need to file a declaration

1. Find out whether the EU ABS Regulation is relevant for your research.
Who is in scope of the Nagoya Protocol?

2. If your research is within scope of by the EU ABS Regulation, go to the ABS Clearing-House to: a) Determine whether the provider country is party to the Nagoya Protocol and whether there is any ABS legislation for genetic resources and/or associated traditional knowledge. b) Obtain the contact information for the national focal point (NFP) and competent national authorities (CNA) in the country that holds the genetic resource and/or the associated traditional knowledge. The ABS Clearing-House should have information on how to apply for access – such as a flow chart or a where you can find more information on how to apply for access. If not, proceed to step

3. Using the ABS Clearing-HouseABS Clearing-House website

Contact the national focal point in your provider country and seek advice as to:

a) How to apply for Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) and if there are any specific requirements or conditions attached to these permits.

b) Other specific and relevant national legislation that requires further permits.

Using ABS Clearing-House

4. Apply for PIC and establish MAT if required. During the research period, the conditions stated in the MAT and other relevant legislation must be fulfilled.

5. During the period of your research you shall declare due diligence to the Swedish Environmental Protection Agency.

User Manual (pdf 1 MB)

6. If you launch a product in the market as a result of this research, you shall, before the product is introduced in the market or at the time of the product approval, submit a second declaration to the Swedish Environmental Protection Agency.

User Manual (pdf 1 MB)

Other obligations under the EU ABS Regulation.

7. Keep your permits (PIC AND MAT) and any other information relevant to access and benefit-sharing for 20 years after the research is concluded.

8. Inform subsequent users of the conditions as described in PIC and MAT.

For the purposes of this Regulation, the definitions of the Convention and the Nagoya Protocol as well as the following definitions apply:

Access means the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol

Association of users means an organisation, established in accordance with the requirements of the Member State in which it is located, that represents the interests of users and that is involved in developing and overseeing the best practices referred to in Article 8 of this Regulation

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

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

Illegally accessed genetic resources means genetic resources and traditional knowledge associated with genetic resources which were not accessed in accordance with the national access and benefit-sharing legislation or regulatory requirements of the provider country that is a Party to the Nagoya Protocol requiring prior informed consent

Internationally recognised certificate of compliance means a permit or its equivalent issued at the time of access as evidence that the genetic resource it covers has been accessed in accordance with the decision to grant prior informed consent, and that mutually agreed terms have been established for the user and the utilisation specified therein by a competent authority in accordance with Article 6(3)(e) and Article 13(2) of the Nagoya Protocol, that is made available to the Access and Benefit-sharing Clearing House established under Article 14(1) of that Protocol

Traditional knowledge associated with genetic resources means traditional knowledge held by an indigenous or local community that is relevant for the utilisation of genetic resources and that is as such described in the mutually agreed terms applying to the utilisation of genetic resources

User means a natural or legal person that utilises genetic resources or traditional knowledge associated with genetic resources

Utilisation of genetic resources  means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention

Prior informed consent (PIC) a permit or an equivalent document that has been issued at the time of access as proof of the compliance of applicable laws and regulations

Mutually agreed terms (MAT): a contract between a provider of genetic resources or associated traditional knowledge and a user, within which the obligations are described that ensures that any potential benefit is shared fairly and equitably. Additional requirements may exist for subsequent users or at the time of product release to market

Background

The aims of the UN Convention on Biological Diversity (CBD) are the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. At the Conference of the Parties to the Convention on Biological Diversity (CBD) in 2010, the Nagoya Protocol governing access to genetic resources and fair and equitable sharing of their use was adopted.

In the EU, the Nagoya Protocol is implemented by Regulation (EU) No 511/2014 of the European Parliament and of the Council on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (also called the ABS Regulation).

This Regulation entered into force in October 2014. On 12 October 2015, one year after its entry into force, the Regulation’s provisions on the obligations of users of genetic resources began to apply within the EU.

Sweden ratified the Nagoya Protocol September the 6, 2016 and became a full member on December 7, 2016. Since the 1 of October there is an ordinance in Sweden on the use of genetic resources and associated traditional knowledge (SFS 2016: 858). The ordinance provide provisions and obligations in Sweden in regards to the Nagoya protocol and the EU ABS legislation.

Implementation of the ABS Regulation in Sweden

In February 2015, the Swedish Environmental Protection Agency was given the commission by the Government of Sweden to prepare for the implementation of the EU Regulation 511/2014 (ABS Regulation) on the implementation of the Nagoya Protocol. A report on this commission was presented on 31 March 2016.

Report (Only in Swedish, pdf 223 kB)

In January 2016 the Swedish Environmental Protection Agency was appointed as the single authority i.e. the only competent authority in Sweden, CNA. It is the responsibility of the Swedish Environmental Protection Agency to review and check due diligence declarations of users. For more information on what it means see the text under the heading Declaring due diligence, on the webbpage "Using genetic resources from other countries". The Swedish Environmental Protection Agency is also responsible for verifying applications for registration of collections and making regular checks on these.

Who is in scope of the Nagoya Protocol?

In the following section it is explained who is affected by the Nagoya Protocol and the EU ABS Regulation.

Regulations on access and benefit-sharing (ABS) apply both to commercial and non-commercial researchers.

Both researchers conducting basic research, and those conducting applied research on biological material and/or associated traditional knowledge, shall comply with these regulations.

  • Biological material (genetic resources) is needed for the research
    A genetic resource (GR) is material from plants, animals, microorganisms or other origin that contains genetic information. Derivatives can also be included as genetic resources, such as proteins, lipids, enzymes, RNA and organic compounds such as flavonoids, essential oils and plant resin.
  • Associated traditional knowledge is needed for the research
    Associated traditional knowledge (aTR) is traditional knowledge possessed by indigenous peoples or local communities that is relevant for the use of the genetic resources.
  • The material is obtained in a country other than the country of the research
  • The material is obtained in a country other than Sweden (as Sweden do not have any ABS access legislation) 

If the material is obtained from a country other than the country in which you conduct research, you must find out the following information:

  • Is provider country party to the Nagoya Protocol or have they ratified it? See the ABS-CH website. 
  • Does provider country have access legislation? (contact country’s National Focal Point (NFP)
    Check the ABSCH. 

    Select the country to which you plan to travel to and check “Legislative, administrative or policy measures on the access and benefit-sharing (MSR)”. There you will find the regulations and ordinances that are applicable to the country in question. Under “Access” you will find any access legislation the country has. If it is unclear, contact the country’s National Focal Point (NFP) who’s contact details you can find on the same webpage. Information about this can be found on the same page.

Frequently asked Questions

Questions and answers on the Nagoya Protocol and the EU ABS Regulation and the use of genetic resources and associated traditional knowledge in research and product development.

Using the ABS Clearing-House

Here you will find information on how to use the ABS Clearing-House to find the right information about the country from which your genetic resource or traditional knowledge came from.

If your research falls within the framework of the Nagoya Protocol and the EU ABS Regulation, you may visit the ABS Clearing-House (ABSCH) Internet tool to obtain all the necessary information about the country from which your genetic resource or traditional knowledge came from.

ABSCH is a platform and distribution institution for the exchange of information about access and the allocation of benefit and is a part of the clearing-house mechanism. ABSCH is a key tool to simplify the implementation of the Nagoya Protocol by enhancing the rule of law, and increasing the clarity and insight into the procedures for access and supervision of the utilisation of genetic resources. By providing relevant information on ABS (Access and Benefit-Sharing), ABSCH provides opportunities to link up access countries with users of genetic resources and associated traditional knowledge.

In it you will find:

  • Information as to whether the provider country is party to the Nagoya Protocol and whether the country applies access legislation.
  • Contact details for the national focal point (NFP) in the provider country.
  • Contact details for the competent authority (CNA) in the provider country
  1. Enter the website. 

ABSCH website

  1. Click on the country from which you intend to obtain the resource or select the country from the list. 
  2. Click on “view country profile”. There you will find all available information on ABS in the provider country. The countries’ national registers are published by the governments and contain national information that is relevant for the implementation of the Nagoya Protocol as well as information that the parties are obligated to provide, according to the protocol.
The national registers contain the following information

ABS National Focal Point (NFP) – Responsible for contact with the CBD secretariat and is the body that is to provide information on procedures for access to genetic resources and associated traditional knowledge and for the preparation of mutual agreed terms (MAT). NFP is also responsible for information on competent national authorities, domestic and local bodies and other affected stakeholders. 

Competent national authorities (CNA) – Authorities that are designated to be responsible for providing advice on the permit procedure, how to establish mutual agreed terms (MAT) and how to obtain prior informed consents (PIC). They are also, where applicable, responsible for the issuance of written certificates showing that the access requirements have been fulfilled. 

Legislation, administrative or political measures for ABS (MSR) – Measures adopted on the national level to implement the Nagoya Protocol access and distribution obligations. Here you can see whether a country has access legislation or not. 

National websites and databases (NDB) – Information and links to national websites or databases that are relevant for ABS. Here you can find information on the procedure for access to genetic resources and/or associated traditional knowledge.

Internationally Recognized Certificate of Compliance (IRCC)  A permit or 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.

Checkpoints (CP) In the EU these are checkpoints at which you as a user declare due diligence. You do this on two occasions. 1) after the first partial payment of research funding has been received or not later than the end of the project or when the final report is submitted. 2) in the final development stage of a product. The time for the first declaration applies even if no further product development occurs. In Sweden the declarations are sent to the Swedish Environmental Protection Agency.

Checkpoint Communiqués (CPC) – A summary of the information that has been gathered in or received by a checkpoint (CP). In the EU the declarations on due diligence are the checkpoint communiqués. Approved declarations are then forwarded to ABSCH or if the declarations contain confidential information directly to the original access country.

Declaring due diligence

You must show that you comply with 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 submit a due diligence declaration on two occasions:

  1. after the first partial payment of research funding has been received or not later than the end of the project or when the final report is submitted. This applies even if no further product development occurs.
  2. in the final development stage of a product.

You must submit your declaration of due diligence using the data submission tool “DECLARE”. Articles 5-6 of the EU’s Implementation Regulation contain more detailed information about when to submit declarations. The procedure for submitting a declaration can be found in the User Guide for the DECLARE NAGOYA IT system.

DECLARE data submission tool

Using Swedish genetic resources

Sweden has no specific legislation governing access to Swedish genetic resources. This means that users do not need informed consents and agreements under the Nagoya Protocol in order to utilise Swedish genetic resources.

However, there is legislation that restricts or prohibits all utilisation of some species in Sweden.

It is prohibited to collect certain species of plants and animals if they are protected by law or in other ways.

Check the legislation applicable to the particular species from which the genetic resource will be accessed. One such piece of legislation that you should check is Sweden's Artskyddsförordning (2007:845) (the Swedish Species Protection Ordinance).

Species Protection Ordinance

If you want to conduct research or ex-situ conservation in Sweden on an invasive alien species, you may need a permit.

The Swedish Environmental Protection Agency is responsible for invasive alien species living on land and the Swedish Agency for Marine and Water Management for invasive alien species living in water.

If you want to use a species covered by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), you might also need apply for a CITES permit. In the EU, CITES is implemented through Council Regulation (EC) No 338/97.

Almost all plant and animal species as well as fungi and other organisms in Sweden that are found outside protected areas such as nature reserves and national parks can be used with only the permission of the landowner, or under Sweden’s right of access to private land (allemansrätten).

You can utilise a genetic resource without the landowner’s permission if it is obvious that the resource has no economic value for the landowner and your utilisation does not cause any harm to the landowner.

You may need an exemption or permit under Sweden’s Environmental Code from the county administrative board, or in some instances the municipality, if the genetic resource is found in a nature reserve or a national park.

Using traditional knowledge related to genetic resources

Traditional knowledge that relates to genetic resources is traditional knowledge possessed by an indigenous people or a local community and that is relevant for the utilisation of genetic resources. The knowledge-bearer is the right-holder where traditional knowledge relating to genetic resources is concerned. It is the knowledge-bearer who can approve the access to traditional knowledge.

It is your obligation to obtain the permits and consents required to access the knowledge. If you plan to use a genetic resource by utilizing a traditional knowledge you must show that you fulfil the due diligence obligations as described in article 4 in the EU ABS regulation (No. 511/2014). This means that you must be able to show that you have relevant permits and consents.

You must also be able to show an international recognized certificate of compliance and information on such content in the mutually agreed terms as is relevant for subsequent users. If this is not possible you, as a user of traditional knowledge, must be able to show how, when and where the access occurred. You must also be able to show that there is an agreement in place to ensure fair and equitable sharing of any benefits that may arise from this utilisation. A due diligence declaration should then be submitted no later than the finalization of the research project. A second declaration should be submitted if a product has been produced as a result of the utilisation and is ready to be introduced in the market.

You are also required to keep the information that is relevant to the assessment of whether due diligence has been shown for 20 years after the close of the utilisation period.

There is no special regulation of access to traditional knowledge in Sweden, nor are there any plans to institute any such regulation as a result of the ABS Regulation. 

If you plan to use traditional knowledge that relates to genetic resources you need to declare “due diligence” to the Swedish Environmental Protection Agency (regardless of where the knowledge comes from, except if the traditional knowledge is from Sweden).

You must show that you comply with 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 submit a due diligence declaration on two occasions:

  1. after the first partial payment of research funding has been received or not later than the end of the project or when the final report is submitted. This applies even if no further product development occurs.
  2. in the final development stage of a product.

You must submit your declaration of due diligence using the data submission tool “DECLARE”. Articles 5-6 of the EU’s Implementation Regulation contain more detailed information about when to submit declarations. The procedure for submitting a declaration can be found in the User Guide for the DECLARE NAGOYA IT system.

”DECLARE” data submission tool 

User Manual (pdf 1 MB)

Using genetic resources from other countries

Guidance as to what you need to do in Sweden if you want to use genetic resources located in a different country.

Granting research funding and approving products

As research funding provider or product approval authority you play a key role as information disseminator and link to users of genetic resources. 

You can contribute to the effective implementation of the ABS Regulation by informing the users of the requirements imposed upon them in conjunction with the assignment of public or private research funding and the final stage of product development.

You may disseminate the following information in conjunction with the announcement of research funding and prior to the final approval of a product. Links can be found under the "Laws/Regulations" tab, above.

  • The ABS Regulation applies to all genetic resources except:
    - the human genome 
    - genetic resources that fall outside the sovereign rights of a country, e.g. marine areas outside national jurisdiction (international waters) and areas covered by the Arctic treaty
    -genetic resources for food and agriculture used within the framework of the International Treaty on Plant Genetic Resources for Food and Agriculture and
    -Influenza preparedness framework for influenza virus with pandemic potential, the so called PIP framework (Pandemic Influenza Preparedness
  • The ABS Regulation applies on the condition that the access country is a party to the Nagoya Protocol and that the county has national access legislation.
  • The ABS Regulation is applicable to accesses to genetic resources carried out after 12 October 2014.
  • Further information regarding time and the procedure for making a declaration in conjunction with the assignment of research funding and in conjunction with the final approval of a product is given in Article 5 and Article 6, respectively, of the ABS Implementation Regulation (EU) 2015/1866.
  • Spot checks of users’ compliance will be conducted by the Swedish Environmental Protection Agency in accordance with a risk-based control plan.
  • The user must clearly mark, in his or her declaration, any information that is confidential. 

You must show that you comply with the access legislation of the country in question. You must show this by obtaining prior informed consents (PIC) and establishing mutually agreed terms (MAT) and by declaring due diligence in accordance with the ABS Regulation.

You must submit a due diligence declaration on two occasions:

  1. after the first partial payment of research funding has been received or not later than the end of the project or when the final report is submitted. This applies even if no further product development occurs.
  2. in the final development stage of a product.

You must submit your declaration of due diligence using the data submission tool “DECLARE”. Articles 5-6 of the EU’s Implementation Regulation contain more detailed information about when to submit declarations. The procedure for submitting a declaration can be found in the User Guide for the DECLARE NAGOYA IT system.

”DECLARE” data submission tool 

User Manual (pdf 1 MB)

The Swedish Environmental Protection Agency requests that all recipients of research funding (Article 7.1 of EU Regulation No. 511/2014), that pertains to the use of genetic resources and traditional knowledge concerning such resources, must declare due diligence.

On 12 October 2014 the Nagoya Protocol and the EU ABS Regulation came into effect. This implies that anyone who conducts research on genetic resources and traditional knowledge about such resources must have permission for the use of such material (PIC) and must have established an agreement (MAT) as to how the research will benefit the host country. Any user who has accessed genetic resources and traditional knowledge after 12 October 2014 is required to declare so-called due diligence.

Due diligence implies that the user must show that the genetic resource was obtained in accordance with applicable legislation in the country in question and that the potential benefit of the genetic resource must be distributed in a reasonable and fair manner. Exceptions are research on the human genetic heritage, pandemic influenza virus that is covered by the WHO’s PIP framework, genetic material that has been obtained from international waters, and plant genetic material that is included in Appendix 1* of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGFA). For any questions concerning the regulations and the declaration of due diligence, please contact the Swedish Environmental Protection Agency.

* Appendix 1: Plant genetic material that is included in the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGFA) (pdf)

Use of links encouraged

We encourage the use of links from your website to the Swedish Environmental Protection Agency’s information.