Biological and Biotechnological Research

Research in biology and biotechnology involves legal and ethical obligations. This page provides an overview of researchers' responsibilities.

The following sections outline two important compliance areas in biotechnology research: the use of genetic resources under the Nagoya Protocol, and the legal requirements governing the use and dissemination of genetically modified organisms (GMOs), pathogens, or alien species.

Use of genetic resources and the Nagoya Protocol

Biotechnology research and other biological research may involve collecting, analysing or disseminating biological material from plants, animals, microorganisms or the environment. In legal and policy contexts, these materials are referred to as genetic resources.

Research involving genetic resources and the traditional knowledge associated with them raises ethical issues.  The Nagoya Protocol on Access and Benefit-sharing aims to address those issues by regulating access to genetic resources and the fair and equitable sharing of benefits arising from their use. 

Switzerland ratified the Protocol in 2014 and implements it through the Nagoya Ordinance (ONag). 

Scope of the Nagoya Protocol

The Nagoya Protocol applies to research that uses non-human genetic resources, including plants, animals, microorganisms, or their parts, as well as derivatives such as enzymes, proteins, or metabolites. Here, “uses” means research and development on the genetic or biochemical composition of these resources.

The rules apply to both basic and applied research, whether commercial or non-commercial.

Human genetic resources are not covered. Some resources may instead fall under specialised international instruments, such as the  International Treaty on Plant Genetic Resources for Food and Agriculture.

Access and Benefit Sharing

The Nagoya Protocol is based on the principle of Access and Benefit Sharing (ABS). This means that researchers may need to obtain permission before accessing or using genetic resources from another country, and that benefits arising from the research should be shared fairly with the provider country or community.

In practice, researchers should:

  • check the access rules of the provider country
  • obtain Prior Informed Consent, where required
  • agree Mutually Agreed Terms before using the material
  • respect any conditions on collection, export, transfer, publication, data sharing or commercial use
  • keep records of permits, agreements and the origin of the material

Benefit sharing does not necessarily mean financial payments. It may also include collaboration, co-authorship, sharing of data or results, training, capacity building, or technology transfer.

Even where no Nagoya obligation applies, researchers should follow good scientific practice and consider fair collaboration, transparency and benefit sharing with local partners and communities.

Before starting a project

Researchers planning biodiversity research should assess possible Nagoya Protocol obligations as early as possible, ideally during project design or grant preparation. This is particularly important when collecting, importing, sequencing, transferring, or publishing data from biological material of foreign origin.

ABS procedures may take several months, and provider countries may impose conditions on access, export, research use, collaboration, publication, or data sharing.

Links

The Nagoya Protocol on Access and Benefit-sharing

Nagoya Protocol page by the Federal Office for the Environment

Nagoya Ordinance (NagO)

Access and Benefit-sharing Clearing-House

Contact

Knowledge and Technology Transfer Service

Use and dissemination of GMO, alien species or pathogens

If your research involves the use or dissemination of GMOs, alien species or human, plant or animal pathogens, it is subject to regulations by the Federal Office for the Environment (FOEN). The applicable regulations depend on the research being conducted.

If you have a question on this topic, please contact:

  • Dr. Laurent Poirel (Biosafety Officer for the Section of Medicine) for medically relevant aspects (e.g. human pathogens, medical applications of GMOs)
  • Prof. Didier Reinhardt (Biosafety Officer for the Department of Biology) for plant, animal, or environmental aspects (e.g. non-human pathogens, invasive species, environmental release)

For questions relating to the planning of specific research activities (authorizations, Ecogen procedures, biosafety compliance), please contact the Biosafety Officer of your department.