• 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.

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.

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

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

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.

• 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.

1. 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.
2. 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.
3. Negotiating and agreeing the terms of access (MAT). These mutually agreed terms 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.
4. Upon receipt of PIC and MAT, the providing country can also issue an Internationally Recognised Certificate of Compliance (IRCC) to prove that access to the genetic resource was legal and MATs have been established.
5. Adhere to the conditions of the PIC and MAT throughout your research.
6. Keep all documents for 10 years after completion of your research (20 years according to EU law). These documents can be inspected by the supervisory authority.

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

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).

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.

• 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.