• The Protocol provides that the benefits arising from the utilisation of genetic resources or traditional knowledge associated with these resources should be shared with those who provide these resources or knowledge. 
• The Protocol also defines how access to genetic resources should be regulated and thus facilitates access to these resources for companies and research organisations.
• The Protocol contains provisions to ensure that those who utilise genetic resources or the traditional knowledge associated with them comply with the applicable Access and Benefit Sharing (ABS) regulations in the provider countries.
• The Protocol is also intended to increase legal certainty in the handling of genetic resources and related traditional knowledge. This is necessary for companies and the scientific community to invest in research and development.
• The provisions of the Nagoya Protocol are addressed to the Parties to the Protocol and must be implemented by them at national level.

The Nagoya Protocol applies to:

• basic, academic or non-commercial research (as well as commercial research);
• non-human genetic resources originating from outside Switzerland whether they are obtained from:
  • the country of origin of the genetic resource;
  • outside the country of origin, for example, a botanical garden in Switzerland;
  • non-wild sources such as zoos;
  • laboratory grown materials (in some cases).

The Nagoya Protocol does not apply to:

• human genetic resources;
• genetic resources as traded commodities without (later) research and development;
• genetic resources that are governed by specialised international ABS instruments (such as the International Treaty on Plant Genetic Resources for Food and Agriculture);
• genetic resources originating from countries that do not have ABS regulations restricting access to genetic resources.

• A genetic resource in the context of Access and Benefit Sharing (ABS) encompasses more than DNA and RNA. It is any material of plant, animal, microbial or other origin that contains functional units of heredity and 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 that are already regulated by specialised international instruments (e.g. the International Treaty on Plant Genetic Resources for Food and Agriculture),
  • pandemic influenza strains covered by the Pandemic Influenza Preparedness Framework, genetic resources located outside national jurisdictions, e.g. on the high seas.
• Utilisation means the research and development of the genetic and/or biochemical composition of genetic resources or derivatives, including through the application of biotechnology.
• Genetic resources are often closely linked to the traditional knowledge of indigenous peoples and local communities. Traditional knowledge can consist of innovations, practices, know-how or skills that are developed, maintained and passed on from generation to generation within a community.
• Prior Informed Consent (PIC) is a unilateral declaration by the competent authority of the provider country and/or indigenous peoples and local communities.
• Mutually Agreed Terms (MAT) is a contract negotiated between the user and the provider of genetic resources. It is also referred to as a benefit-sharing agreement. It specifies how the benefits arising from the utilisation of the genetic resource are to be shared (e.g. profit sharing, technologies, know-how or other), as well as dispute settlement clauses and subsequent utilisation by third parties. In some countries, there are standard clauses for MATs.
• A Material Transfer Agreement (MTA) is an agreement between institutions that sets out the conditions for the transfer of samples or specimens. This is not to be confused with MAT - Mutually Agreed Terms - although a MAT can also be included in an MTA.

A glossary with the most important terms of the ABS system can be found here.

The Access and Benefit Sharing (ABS) system describes how researchers can gain access to genetic resources and share the benefits fairly and equitably between those who use them and those who provide them.

The ABS system in a nutshell:

• Follow national laws (national Access and Benefit Sharing (ABS) regulations of the provider country and the country to which you are bringing the material to be analysed, e.g. Switzerland).
• Obtain prior informed consent (→ definition of terms) from the provider.
• Negotiate mutually agreeable terms with the provider (→ definition of terms).
• Share the benefits of use fairly and equitably.

Be aware that although some countries are not parties to the Nagoya Protocol, they may still have national legislation on access to and export of plant, animal or bacterial material that you must comply with.

If no national legislation applies, you still have an ethical responsibility to act in accordance with good scientific practice when accessing genetic resources. In some circumstances, this could still mean sharing the benefits from the utilisation of genetic resources fairly.

If you need help with any of these steps, please contact the Good Research Practice Contact Point.

1. Check whether the Nagoya Protocol applies to your work.

• Who? Researchers who intend to obtain a non-human genetic resource that originates from another country.
• What? Check whether your research falls into the area of application of the Nagoya Protocol. Please use this self-assessment (upcoming) to do so. 
• Why? You have the legal obligation to comply with any applicable ABS measures.
• When? Complete this step as early as possible when planning a research project e.g. when preparing the grant proposal.  

2. Document and record your decision.

• Who? Researchers who intend to obtain a non-human genetic resource that originates from another country.
• What? If, in the first step, you conclude that the Nagoya Protocol does not apply to your work, please document the justification for this conclusion and send it into the centralised Nagoya database, held by the Good Research Practice Contact Point. Also keep the justification in your records for 10 years. 
• Why? As evidence to show the assessment that the genetic resource/traditional knowledge wasn’t within scope of the Nagoya Protocol or ABS law. The Swiss competent authority may inspect these records. Also, should a current non-Nagoya Protocol country in the future join the Nagoya Protocol and/or or implement new ABS access measures relating to genetic resource you previously acquired, it is relevant to have documented the historical ABS position applying to your earlier access and use, particularly if you intend to access additional samples of that genetic resource from that country.
• When? You should create this record at the time you judged that there aren’t any Nagoya Protocol obligations.

3. Comply with national law. Familiarise yourself with national rules and contacts.

• Who? Researchers intending to use genetic resources/traditional knowledge that has ABS requirements under the Nagoya Protocol.
• What? If the Nagoya Protocol applies to your work, you will need to comply with the national law of the country of origin of the genetic resources/traditional knowledge you are using. The Access and Benefit-Sharing Clearing-House (ABSCH) is an online platform for the exchange of all relevant ABS information between stakeholders in different countries that are Parties to the Nagoya Protocol. There, you will find the national legislation on access to genetic resources (if there is any) as well as information on the national contact point, the competent national authority or other important control points. Please note that relevant information on some countries may be missing on the website. If in doubt, contact the national contact point or local competent authority for advice.
  
  Please be aware that some countries (whether a Party or Non-Party to the Nagoya Protocol) may have their own ABS legislation, unrelated to the Nagoya Protocol, that governs the access and use of their genetic resources for research that should also be followed. For example, Digital Sequence Information (DSI) may be in-scope of a country’s domestic ABS measures even if the activities don’t fall within the scope of the Nagoya-ABS rules. You are obliged to follow the ABS law of the provider country.
• When? As early as possible. Ideally when planning a research project, e.g. when preparing the grant proposal.

4. Submit an ABS application/request to the provider country to access the genetic resource/traditional knowledge in order to obtain Prior Informed Consent and negotiate and agree the terms of access (MAT).

• Who? Researchers intending to use genetic resources/traditional knowledge that has ABS requirements under the Nagoya Protocol.
• What? Make every effort to obtain prior, explicit and informed consent. If required by national regulations, you are obliged to obtain Prior Informed Consent (PIC) from the provider country (where the genetic resource is found in situ) and, if applicable, from other providers such as an indigenous community, before acquisition. Start by contacting the national contact point of the country of origin of the genetic resources/traditional knowledge you wish to use. You may not start using the genetic resource/traditional knowledge before having obtained PIC.
  
  These mutually agreed terms (MATs) should cover the way in which research results are disseminated, the publication or other sharing of research data and possible utilisation. The MAT will specify monetary and/or non-monetary benefit-sharing measures and what may be done with the product. Make sure that the MAT authorises all measures you plan to take (e.g. export, sequencing, sharing data with research partners, publication) and confirm that the data will cover the entire duration of your research project. If your research project is carried out in collaboration with other organisations, make sure that they are all listed in the MAT.
  
  Remember that MATs are contractual obligations and that the terms must also be practicable or useful for you and your research team.
  
  The Swiss Academy of Sciences offers an external site that contains a helpful toolbox for sample MAT clauses. Unitectra can support you in drafting MATs.
• When? As early as possible. Some countries’ ABS procedures may take several months or more to complete.   

5. Document the legality of your use of genetic resources/traditional knowledge.

• Who? Researchers intending to use genetic resources/traditional knowledge that has ABS requirements under the Nagoya Protocol.
• What? Please keep proof of legality of access and use in your records for 10 years and send a copy to the centralised Nagoya database, held by the Good Research Practice Contact Point. These documents can be inspected by the supervisory authority. The following documents should be stored if Nagoya Protocol obligations apply: 
  • the date and place the genetic resources and associated traditional knowledge were acquired;
  • a description of the samples and any identifiers;
  • the source from which the items were obtained;
  • any terms and conditions governing access and benefit sharing (e.g. the PIC, MAT);
  • if applicable: Internationally Recognised Certificate of Compliance (IRCC), issued by the provider country upon receipt of PIC and MAT, which proves that access to the genetic resource was legal and MATs have been established.
• When? As soon as you obtained PIC and concluded the MAT, ask for an IRCC. Document everything immediately.

6. Access and utilise the genetic resource/traditional knowledge.

• Who? Only researchers who have express permission from the provider country .
• What? Access and utilise the genetic resource/traditional knowledge in full compliance with the terms of the ABS approval/agreement. Adhere to the conditions of the PIC and MAT throughout your research.
• When? After having gathered all documentation that proves the legality of your access to the genetic resource/traditional knowledge. 

7. Transfer genetic resources/traditional knowledge governed by ABS law/Nagoya Protocol obligations to a third party/collaborator.

If you wish/need to transfer the genetic resource/traditional knowledge, be aware that this may only be done if you have express permission from the provider country and in accordance with requirements set out in the Prior Informed Consent (PIC) and the Mutually Agreed Terms (MAT). Do not make any transfer unless it is permitted.  

Ensure an appropriate research agreement is in place with the collaborator/third party, such as an Material Transfer Agreement (MTA) or collaboration agreement before you transfer the samples. Contact Unitectra for help. 

The provider country may:

• choose to include the collaborator/third party, who is receiving the genetic resource from you, as a party to the MAT;
• permit you to transfer the genetic resource and/or traditional knowledge to such collaborator/third party under the University’s own arrangements.

Many countries issue an 'internationally recognised certificate of compliance (IRCC)'. If so, this document contains all the relevant information you need to share with your partner/collaborator.

In case the IRCC does not exist, you should pass on the following ‘equivalent information’ to your research partner:

• date and place of access to genetic resource and/or traditional knowledge;
• description of the genetic resource;
• the source from which the genetic resource was directly obtained (and any subsequent users);
• the presence or absence of rights and obligations related to access and benefiting sharing;
• Mutually agreed terms (MAT), if available and if appropriate;
• access permit, if applicable.

This includes transfer to other individuals in the University as well as external organisations. 

_____

More detailed explanations and steps for accessing genetic material in-situ and ex-situ can be found in this guide.

You should establish whether the Nagoya Protocol or ABS obligations apply at the earliest point in your research project plans and ideally at pre-award stage. Please refer to the Step-by-step guidance here above. 

Where it is likely that the Nagoya Protocol will apply, you should inform potential collaborators and/or funders that:

• access to the genetic resources may be subject to the relevant provider country’s laws,
• terms and conditions may be placed on access, export and utilisation by the researcher and any related collaborators, and
• timelines may be increased as a result.

You may find it helpful when planning your research to review section 2 and 3 in the ‘Building your ABS Strategy’ guidance developed by the German Nagoya Protocol hub.

Tips:

1. If possible, identify a partner organisation in the country from which you wish to obtain genetic resources, as this will help to understand and comply with ABS requirements. Some countries require you to find a local collaborator.
2. Allow sufficient time to obtain ABS approvals into your project plans. Depending on the country, this may take several months or longer. You should consider starting this process before project funding is approved; the timeframes in your grant application could be affected.
3. Consider how much of your funding budget might be applied to financial contributions to access and benefit sharing and/or costs of obtaining access to genetic resources.
4. Consider whether you would accept any possible access and benefit sharing provisions required under the country’s ABS and Nagoya Protocol requirements. For example, you may need to provide access to your results, include them in publications, provide training, etc.

Switzerland ratified the Nagoya Protocol on 11 July 2014. The Protocol and the associated amendments to the Federal Act on the Protection of Nature and Cultural Heritage (NCHA) entered into force for Switzerland on 12 October 2014. The Federal Council adopted the Nagoya Ordinance on 11 December 2015. It entered into force on 1 February 2016.

The Nagoya Ordinance (NagO) serves to concretise the provisions on genetic resources in the Nature and Cultural Heritage Protection Act (NCHA Art. 23n - q and 24h para. 3) as well as the further implementation of the Nagoya Protocol in Switzerland:

Section 1 NagO describes the subject matter and the relevant terms (Art. 1 and 2). Among other things, the terms "genetic resources" and "utilisation of genetic resources" are defined.

Section 2 defines the requirements for the utilisation of genetic resources and associated traditional knowledge stemming from other Parties to the Protocol:

• Information that must be recorded, stored and passed on to subsequent users as part of the due diligence obligation can be found in Article 3.
• Article 4 specifies the reporting obligation. Compliance with the due diligence obligation must be reported to the Federal Office for the Environment (FOEN) before the market authorisation or marketing of products whose development is based on a utilised genetic resource.
• According to Article 5, the provisions of Articles 3 and 4 also apply mutatis mutandis to the utilisation of traditional knowledge in accordance with Article 23p NCHA.
• Articles 6 and 7 create the possibility of recognising best practices and collections. Recognised methods and collections shall be published in a public register maintained by the FOEN.

Section 3 regulates access to genetic resources in Switzerland:

• Article 8 states that access to genetic resources in Switzerland must be documented and that this documentation must be reported to the FOEN prior to the market authorisation or commercialisation of products derived from these utilised genetic resources. For genetic resources for which the information is already recorded in the context of other procedures and made available to the FOEN in global form, the users may be exempted from this reporting obligation.
• Article 9 authorises financial assistance for the conservation and sustainable use of genetic resources.

Section 4 describes the tasks of the authorities:

• According to Article 10, the FOEN is the competent authority for the Nagoya Protocol. Among other things, it is the contact point for the Nagoya Protocol and the reporting centre for receiving reports in accordance with the Nagoya Ordinance. The FOEN encourages users to voluntarily share the benefits arising from the utilisation of genetic resources or traditional knowledge associated with them in a fair and equitable manner, even in the absence of a legal obligation, and to work for the conservation of biodiversity.
• Article 11 defines the tasks of other authorities in the context of market authorisation procedures. These check whether or not the registration number is available as proof of notification for products whose development is based on utilised genetic resources or traditional knowledge relating to them. They refuse authorisation as long as the user has not provided the proof.

Section 5 contains the final provisions:

• Article 12 refers to the amendments to other enactments listed in the Annex.
• Article 13 states that the Ordinance will enter into force on 1 February 2016, with the exception of Article 8, which will not enter into force until 1 January 2017.

Switzerland ratified the Nagoya Protocol in 2014. The legal bases for the legal utilisation of genetic resources in Switzerland are:

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

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

• the genetic resource is accessed after 12 October 2014,
• and the genetic resource originates from a State Party to the Nagoya Protocol AND that has national Access and Benefit Sharing (ABS) legislation.

Then you must fulfil a due diligence obligation, i.e. you must archive and pass on the information described in Art. 3 of the Nagoya Ordinance. As soon as a research product is commercialised, you are obliged to report this to the Federal Office for the Environment. You also have similar obligations with regard to access to genetic resources in Switzerland (see Art. 8 of the Nagoya Ordinance).

In any case, you are obliged to comply with the national laws of the provider country.

Researchers who utilise genetic resources that are funded by the European Union may also have to comply with the EU Access and Benefit-Sharing Regulation (EU ABS Regulation).

Federal Office for the Environment FOEN
Biotechnology Section
CH-3003 Bern
Switzerland

E-Mail: contact.np@bafu.admin.ch

Failure to comply with Nagoya-related rules can cause serious reputational damage, result in substantial fines, terminate your research and, in some countries, lead to imprisonment.

The fines in Switzerland are up to CHF 40,000 for negligence and CHF 100,000 for wilful omission or misrepresentation (NCHA, Art. 24a). In addition, genetic material can be confiscated and the utilisation (i.e. your research project) can be discontinued.

Be aware that reputational risks and accusations of biopiracy not only harm you, but also other researchers in your field and the University of Bern. Countries can blacklist you or future UniBE researchers by blocking future research licences or imposing entry bans.

Scientific journals increasingly require proof of ABS compliance. You may not be able to publish your results. In the event of non-compliance, published work may be withdrawn, inclusion in collections or patent claims may be refused and research funds already spent may be reclaimed.

You might be held accountable for research misconduct. 

• The Access and Benefit Sharing Clearing House (information centre for access and benefit sharing, managed by the CBD Secretariat) provides information on national ABS measures.
• On the Nagoya Protocol page of the Federal Office for the Environment you will find more detailed information relevant for Switzerland, as well as access to forms and a FAQ document.
• The Swiss Academy of Sciences provides an overview of the application of the Nagoya Protocol in practice for researchers in Switzerland as well as a toolbox for drafting MAT clauses.
• The Nagoya Protocol "Help and Advice" (HuB) focuses on the legal situation in the EU and Germany. It also provides an excellent overview of the ABS system, explanations, useful checklists, success stories and more.
• The EU Guidance Document provides a comprehensive understanding of the ABS system and how it can be applied to your research.
• Video "Nagoya Protocol for Newbies" (Leibnitz Institute DSMZ).
• Video "ABS simply explained".
• ABS Clearing House: Nagoya Protocol - E-learning Courses
• InforMEA: E-learning courses:
  • Introductory Course to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
  • Introduction to Access and Benefit-Sharing
  • Introductory Course ot the Convention on Biological Diversity (CBD)
• The Convention on Biological Diversity (CBD) and the Nagoya Protocol.
• In this international LinkedIn group, you can keep up to date with relevant information and ask questions directly to other researchers.