More information on the Nagoya Protocol

– on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization

The benefit arising from research that uses genetic resources and traditional knowledge must be shared between researchers and local communities or indigenous peoples. This is the point of the Nagoya Protocol to the Convention on Biodiversity.

Access and benefit sharing is regulated by the Nagoya Protocol, the EU’s ABS Regulation and supplementary national legislation. As a researcher, this means that you must establish whether the rules apply to your research and if they do, you must follow them.

Briefly, this involves documenting the material that you use and gaining prior informed consent regarding genetic resources and traditional knowledge before commencing research or starting to develop a product. However, there are some exceptions.

Which research is affected?

You need to read the information below if, in your research, you work with genetic resources, any derivatives of these or related traditional knowledge introduced to Sweden from another country on 12 October 2014 or later.

However, note the following exception: if your research is limited to human genetic resources, certain plant genetic material (see annex 1 to the International Treaty on Plant Genetic Resources for Food and Agriculture, ITPGRFA), pandemic influenza preparedness (PIP) and genetic material obtained from international waters, you are not affected.

There is other Swedish legislation governing the use of Swedish genetic resources. Read more about Using Swedish genetic resources.

When is research affected?

If your research involves genetic resources or traditional knowledge, there are two research phases where you will need to check whether your research is affected:

Before basic research
Before research/development that seeks to develop a potential product.

This means that you may need to seek prior informed consent and mutually agree terms twice within what could be seen as a single project.

What is a genetic resource?

The Convention on Biodiversity and the EU’s ABS Regulation define genetic resources as “genetic material of actual or potential value” and genetic material as “any material of plant, animal, microbial or other origin containing functional units of heredity”. Derivatives, such as proteins, lipids, enzymes, RNA and organic compounds such as flavonoids, essential oils or resins from plants can also be genetic resources even if they no longer contain any functional units of heredity.

What is traditional knowledge?

Traditional knowledge regarding genetic resources is such knowledge that is held by an indigenous people or a local community and is relevant to the use of genetic resources. The traditional knowledge possessed by indigenous peoples and local communities with traditional lifestyles can provide important clues for scientific discoveries. This covers knowledge, innovation and customs for the preservation and sustainable use of biodiversity.

We will help you

In the first instance, it is you as the researcher who has to do the work required to comply with the regulations, but there are support functions within the university able to provide you with both administrative and legal support. Don’t hesitate to contact us. The text below provides general information about which material and which research is affected.

How do you establish whether your research is affected?

If you are working with or planning to work with genetic resources or traditional knowledge linked to genetic resources, you need to find out whether the material you are working with is covered by the Nagoya Protocol, the ABS Regulation or other legislation regulating use. National legislation on access and benefit sharing (ABS) must be complied with irrespective of the country from which the material is obtained. Because the above regulations entered into force at different times, one guiding factor is that material brought to Sweden from 12 October 2014 onwards may be affected. This means that you will need to investigate the situation regarding the material in question, unless this has already been done and documented.

In other words, you need to check whether the material you are working with is affected by the above regulations. The ABS Clearing House website is an easy way to check which countries have signed the Nagoya Protocol. It also provides information about ABS rules. Note that the fact that a country is a signatory to the Nagoya Protocol does not necessarily mean that that country has national rules on access and benefit sharing. The reverse is also true; a country that has not signed the Nagoya Protocol may nevertheless have ABS legislation.

It is important to find out when a material was brought to Sweden. The ABS Clearing House website contains information about when different parts of the legislation gained legal force in different countries.

The Nagoya Protocol makes exceptions for human genetic resources, certain plant genetic material (see annex 1 to the International Treaty on Plant Genetic Resources for Food and Agriculture, ITPGRFA), pandemic influenza preparedness (PIP) and genetic material obtained from international waters.

The national legislation in different countries differs in terms of the definition of what traditional knowledge is. Therefore, if you are uncertain whether or not your research involves traditional knowledge, it is important to get in touch with the country from which the traditional knowledge was obtained.

If you reach the conclusion that your research is not affected, describe how you have established this, reach a conclusion, document it and save your documentation.

If your research is affected

If your research is affected, contact us. Also contact the ABS National Focal Point in the provider country (you will find their contact details on the ABS Clearing House website). If you have a local partner in the provider country, it may be helpful for your partner to assist you in establishing contact. Making contact with the ABS National Focal Point is the first step in formal contact and the work of obtaining necessary consent and entering into the agreements required, including PIC (Prior Informed Consent), MAT (Mutually Agreed Terms) and MTA (Material Transfer Agreement). The Head of Department or equivalent must sign the agreement on behalf of Uppsala University. Note that well thought-through agreements are important to your continued research. The Legal Affairs Division can help you with legal support.

Prior informed consent and mutually agreed terms must be registered in Uppsala University’s central records register. If you do not have a registration number for the case, you will need to create one. Include “Nagoya/ABS” as part of case subject (ärendemening).

Declaration of due diligence

Once prior informed consent and mutually agreed terms are in place, you need to contact johan.dixelius@uu.se to declare due diligence. As a researcher, you must provide the information required to demonstrate and declare due diligence in the Commission’s DECLARE database. We will help you enter the information.

Save consents and agreements

The consents obtained and the agreements entered into on genetic material or traditional knowledge must be registered with the university and saved for at least 20 years so that, where required, both you as a researcher and the university are able to share these documents with others seeking to continue the research, or account for the documents’ existence. Note that if the genetic material or the traditional knowledge is to be shared further with other researchers, information about prior informed consent and mutually agreed terms must also be provided. Remember that consent, agreements and rules do not necessarily allow further research at other higher education institutions or in other countries.

If you do not have a registration number for the case, this needs to be created now. Include “Nagoya/ABS” as part of the case subject (ärendemening). Your department can help you to register the documents.

Consequences of non-compliance

The consequences of failing to comply with the legal regulations may be a fine or up to two years’ imprisonment. On top of this, journals may have rules that mean that results cannot be published and funding bodies may have rules that mean that funding will not be granted.

More information on the Nagoya Protocol

For more guidance on the Nagoya Protocol, genetic resources and traditional knowledge, see information from the Swedish Environmental Protection Agency.

Contact

Contacts:

Joakim Bergström (Medicine and Pharmacy)
Eric Trovalla (Humanities and Social Sciences)
Reihaneh Dehghani (Science and Technology)
Johan Dixelius (Planning Division)
Katarina Trygg (Legal Affairs Division)