Nagoya Protocol

The Access and Benefit Sharing (ABS) framework outlines how researchers can access genetic resources and share the benefits between those who use them and those who provide them in a fair and equitable way.
The ABS Framework in a nutshell:

Follow national laws (domestic ABS regulations of the provider country and the country where you take the material to be analysed, e.g., Switzerland)

Get Prior Informed Consent (¡ú Definition of concepts) from the provider

Negotiate Mutually Agreed Terms (¡ú Definition of concepts) with the provider

Share benefits fairly and equitably

Be aware that while some countries may not be party to the Nagoya Protocol, they may still have national legislation regarding access and export of plant, animal or bacterial material that you need to comply with.

If there is no national legislation that applies, you still have an ethical responsibility to comply with the ABS framework when accessing genetic resources and sharing benefits fairly as a matter of good scientific practice (e.g., see Art. 6 of the ETH Zurich Guidelines on scientific integrity, RSETHZ 414).
 

• A genetic resource in the ABS context, entails more than DNA and RNA. It means any material of plant, animal, microbial or other origin containing functional units of heredity, which has actual or potential value, or derivatives of a genetic resource (e.g., enzymes, proteins, metabolites, lipids, flavonoids, essential oils or resins from plants). Genetic resources can be wild, domesticated or cultivated.
  
  However, the protocol does NOT apply to

human genetic resources
genetic resources already governed by specialised international instruments (e.g., the externe Seite International Treaty on Plant Genetic Resources for Food and Agriculture)
pandemic influenza strains covered by the Pandemic Influenza Preparedness Framework (externe Seite PIP)
genetic resources found outside of a national jurisdiction, e.g., the high seas.

• Utilisation means to do research and to develop on the genetic and/or biochemical composition of genetic resources or derivatives, including through the application of biotechnology.
• Genetic resources are often closely associated with traditional knowledge of indigenous peoples and local communities. Traditional knowledge may be innovations, practices, know-how or skills developed, sustained, and passed on from generation to generation within a community.
• Prior Informed Consent (PIC) is a unilateral declaration of the competent authority of the providing country and/or indigenous peoples and local communities.
• Mutually Agreed Terms (MAT) represent a contract negotiated between the user and provider of genetic resources. It is otherwise referred to as a benefit-sharing agreement. It includes how benefits from the use of the genetic resource will be shared (e.g., share of profits, technologies, know how or other), as well as dispute settlement clauses and subsequent third-party use. Some countries may have standard clauses for MATs.
• Material Transfer Agreement (MTA) is an agreement between institutions outlining terms and conditions for transferring specimens or samples. This is not to be confused with MAT ¨C mutually agreed terms ¨C although MAT could also be included in an MTA.
  
  externe Seite Here you may find a glossary of key terms used in the ABS Framework.

1. The Access and Benefit-sharing Clearing-House (externe Seite ABSCH) is an online platform exchanging all relevant ABS information between actors in different countries which are party to the Nagoya Protocol. You may find national legislation for accessing genetic resources (if they have established any) as well as information on the national focal point, the competent national authority, or other important checkpoints. Be aware that it is possible that relevant information on some countries is missing from the website. In case of uncertainty, contact the national focal point or the local competent authority for guidance.
2. Make all reasonable efforts to gain prior, explicit informed consent. If required by national regulations, you have the obligation to receive a Prior Informed Consent (PIC) permit granted by the provider country (where the genetic resource is found in-situ) and - if applicable ¨C additional providers such as an indigenous community, before acquisition.
3. Negotiate and agree to the terms and conditions of access (MAT). These Mutually Agreed Terms should include how research results will be disseminated, the publication or other sharing of research data and any potential exploitation. The MATs will establish externe Seite monetary and/or non-monetary benefit-sharing measures and establish what can be done with the product. Check that the MAT allows you to do all actions you are planning to do (e.g., export, sequencing, sharing data with research partners, publishing and confirm that the dates cover the entire duration of your research project). If your research project takes place in collaboration with other organisations, ensure that these all are listed in the MAT.
   Keep in mind that the MAT are contractual obligations and that the terms must also be practicable or useful for you and your research team. The Swiss Academy of Science (SCNAT) offers a externe Seite helpful toolbox for model MAT clauses.
4. Once PIC and MAT have been obtained, the providing country may also issue an Internationally Recognised Certificate of Compliance (IRCC) to show that the genetic resource was accessed legally, and MATs were established.
5. Comply with the terms of the PIC and MAT throughout your research.
6. Keep all records for 10 years after your research has ended (20 years under EU law). These documents may be inspected by the regulator.

More detailed explanations and steps to follow accessing genetic materials in-situ and ex-situ, may be found in externe Seite this guide.

Switzerland has ratified the Nagoya Protocol in 2014. The basis for legal use of genetic resources in Switzerland are:

• The Nagoya Ordinance (externe Seite NagO)
• The Federal Act on the Protection of Nature and Cultural Heritage (externe Seite NCHA Section 3c specifically addresses genetic resources)
• Art.49a of the Federal Act on Patents for Inventions (externe Seite PatA)

Under Swiss law, academic researchers who use genetic resources as defined above, have certain legal obligations if

the genetic resource is accessed after 12 October 2014

and the genetic resource comes from a country party of the Nagoya Protocol AND has national ABS legislation in place.

Then you must comply with a due diligence requirement, which means you must record, keep and pass on the information outlined in externe Seite Art. 3 of the Nagoya Ordinance. As soon as a product of research is commercialised, you are required to notify the Swiss Federal Office for the Environment. You also have similar obligations when accessing genetic resources in Switzerland (see externe Seite Art. 8 of the Nagoya Ordinance).

You are always required to comply with any national laws from the provider country.

Researchers who use genetic resources receiving externe Seite funding from the European Union may also need to follow the EU Regulation on Access and Benefit Sharing (externe Seite EU ABS Regulation). 
 

Non-compliance may cause serious reputational damages, entail significant monetary fines, bring your research to a halt and in some countries lead to prison sentences. Fines in Switzerland for negligence are up to CHF 40¡¯000 and CHF 100¡¯000 for wilfully omitting information or providing wrong information (externe Seite NCHA Art. 24a). Genetic material can be seized and utilisation (i.e., your research project) stopped.

Please be aware that any reputational risks and accusations of biopiracy not only harms you, but also other researchers of your department and institution. Countries may blacklist you or future researchers of ETH Zurich, blocking future research permits or installing bans on entering the country. Scientific journals increasingly demand proof of ABS compliance. You may not be able to publish findings. In cases of non-compliance, published papers may be forced to be withdrawn, deposition in collections or patent claims rejected, and research funds already spent can be reclaimed.
 

What is ¡°Digital Sequencing Information¡± DSI?
DSI is a placeholder name that describes various types of information relevant to the utilisation of genetic resources. Terms such as ¡°Genetic or genomic sequence data¡±, ¡°genetic sequence information¡± ¡°dematerialised genetic resources¡±, ¡°nucleotide sequence data¡±, ¡°in silico utilisation¡± are commonly used in practice.
The ABS Capacity Development Initiative has produced a short video explaining the issues surrounding DSI: externe Seite DSI ¨C Simply Explained
At the Conference of Parties to the Convention on Biological Diversity (COP 15) in 2022, it was decided that DSI is a genetic resource under the Nagoya Protocol and the Access and Benefit-Sharing (ABS) framework applies.

Which biochemical molecules are relevant to the discussion of DSI?
Macromolecules such as DNA, RNA, and proteins metabolites, as well as other sequential macromolecules, such as polysaccharides fall under DSI. Sequential information could also describe the sequence of atoms in a biochemical compound expressed by a genetic resource.
Human genetic resources are explicitly excluded from the ABS framework.

How to deal with DSI:

• Some countries already regulate access and benefit-sharing of DSI within their national laws (e.g., Brazil, India, Kenya, South Africa among others). Researchers must always follow the laws of the provider country. Contact the National Competent Authority or National Focal Point of the provider country via the ABS Clearing-House for information and access procedures. National regulation may include the need for an explicit permission by the provider country, to generate sequences from samples of biological material, restrictions on the distribution, use and publication of the resulting data and benefit-sharing obligations.
• When collecting genetic resources for sequencing from any country, ensure to collect information on the country of origin and date of sample collection. When registering samples at one of the main public databases, the European Bioinformatics Institute EMBL-EBI, DNA DataBank of Japan DDBJ and GenBank hosted by NCBI in the USA, adding information on the country of origin and spatiotemporal metadata has become mandatory since 2023. For more information on the new policy by the International Nucleotide Sequence Database Collaboration (INSDC) externe Seite see here.
• To date, there are no changes regarding DSI within regulation in Switzerland.

Establishing a multilateral mechanism
After the decision to officially include DSI into the Nagoya Protocol, a multilateral mechanism for benefit-sharing when using DSI is now being created. There are still many open questions, and the multilateral mechanism is yet to be developed. A working group is tasked to find solutions that will be discussed at the next meeting of the Conference of Parties (COP 16) in 2024.
This guide offers an overview of the discussion surrounding DSI and the ongoing policy process: externe Seite Introductory Guide DSI

• externe Seite Access and Benefit Sharing Clearing House offers information on national measures on ABS.
• On the Nagoya Protocol externe Seite website by the Federal Office for the Environment you may find more detailed information relevant to Switzerland as well as access to forms and the externe Seite FAQ sheet.
• The Swiss Academy of Sciences offers externe Seite an overview on how to apply the Nagoya Protocol in practice for researchers in Switzerland as well a toolbox on how to establish externe Seite MAT clauses.
• The externe Seite Nagoya Protocol HUB focuses on the legal situation in the EU and Germany. It also offers excellent overview of the ABS framework, explanations, useful checklists, success stories and more.
• The externe Seite EU Guidance Document offers a comprehensive understanding of the ABS framework and how it may apply to your research.
• externe Seite The Convention on Biological Diversity and the Nagoya Protocol

• externe Seite ABS simply explained - YouTube
• externe Seite Nagoya for Newbies

In this externe Seite international LinkedIn group you may stay up to date with relevant information and ask questions directly to other researchers.