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Industry & newsHighlights & Swiss Biotech ReportLegal framework and policies

Legal framework and policies

Explore a selection of national and international guidelines relevant to Swiss life sciences companies.

Transparency strengthens trust in pharmaceutical industry cooperation

Pharma Cooperation Code

Code of conduct of the pharmaceutical industry in Switzerland on cooperation with healthcare professionals and patient organizations

The Pharma Cooperation Code (PCC) promotes transparency and trust by requiring signatory pharmaceutical companies in Switzerland to disclose financial benefits provided to healthcare professionals and organizations.

Transparency strengthens public and patient trust in the pharmaceutical industry. The Pharma Cooperation Code (PCC) requires signatory companies in Switzerland to disclose financial benefits provided to healthcare professionals and organizations.

Introduced in January 2014 and revised in 2025, the PCC was developed by scienceindustries in alignment with European pharmaceutical industry transparency standards. Intergenerika, Interpharma and vips also support the code.

What must companies disclose?
Since 2016, signatory companies have published annual information on financial benefits provided during the previous year to healthcare professionals, hospitals, research institutes and other healthcare organizations.

Which benefits are disclosed?
Disclosure covers payments and other financial benefits associated with prescription medicines for human use, including:

  • Consultancy and service fees

  • Financial support for healthcare research and development

  • Contributions toward participation in professional events

Certain benefits are exempt, including customary commercial compensation, permitted free pharmaceutical samples, educational materials of modest value and meals, including beverages.

How are benefits disclosed?
Companies aim to disclose payments individually, identifying recipients wherever consent has been obtained. Where consent is refused, payments are disclosed without identifying the recipients.

Further information
The latest code, disclosure requirements and annual transparency reports are available from scienceindustries.

Legal framework for clinical and non-clinical research in Switzerland

Human research legislation

Explore Switzerland's legal framework for research involving humans, including clinical trials, the use of biological material and health-related personal data, and the requirements for protecting research participants.

Legal provisions on research on humans can be found on several federal acts, the most important being:

Federal Act on Research involving Human Beings

Research involving humans in Switzerland is governed by the Human Research Act (HRA) and its implementing ordinances. The legislation protects the dignity, privacy and health of research participants while establishing appropriate conditions for scientific research, quality and transparency.

The legislation entered into force on January 1, 2014. Its implementing ordinances were revised in 2024, with additional transparency provisions taking effect on March 1, 2025.

Which laws and ordinances apply?

The legal framework includes:

Which research activities are covered?
The legislation covers clinical and non-clinical research involving humans, research involving deceased persons, embryos and fetuses, and the use of biological material and health-related personal data.

Research projects falling within the scope of the HRA generally require authorization from the responsible cantonal ethics committee. Depending on the type and risk category, clinical trials may also require authorization from Swissmedic or the Federal Office of Public Health (FOPH).

Clinical trials are also subject to registration and applicable transparency requirements.

What is the purpose of the legislation?
The framework aims to protect research participants, promote the quality and transparency of human research, and establish proportionate regulatory requirements. The revised ordinances also address digital developments and clarify responsibilities among the competent authorities.

Access to genetic resources and fair benefit-sharing in Switzerland

Nagoya Ordinance

Explore Switzerland's regulations on access to genetic resources and fair benefit-sharing, including requirements for research and development involving genetic resources from Switzerland and abroad.

The Nagoya Protocol, established under the Convention on Biological Diversity, regulates access to genetic resources and the fair and equitable sharing of benefits arising from their use. It supports biodiversity conservation, sustainable use and legal certainty for research and development.

Switzerland ratified the Nagoya Protocol in July 2014. The protocol and related amendments to the Federal Act on the Protection of Nature and Cultural Heritage (NCHA) entered into force in October 2014. The Nagoya Ordinance (NagO), which implements these provisions in Switzerland, entered into force in February 2016.

Which genetic resources are covered?
The ordinance addresses the use of genetic resources from Switzerland and other countries, as well as associated traditional knowledge. It applies to relevant research and development activities in academia and industry, including biotechnology and pharmaceutical research.

What obligations apply?
Researchers and companies must comply with applicable access and benefit-sharing requirements. Depending on the origin and use of the genetic resources, obligations may include:

  • Observing access regulations in the country providing the resources
  • Ensuring fair and equitable benefit-sharing where required
  • Recording, retaining and passing on relevant information
  • Notifying the Federal Office for the Environment (FOEN) before market authorization or commercialization, where applicable

For genetic resources accessed in Switzerland, specific documentation and notification requirements apply. The ordinance provides a framework for traceability and responsible use.

More

Further ordinances

  • Ordinance on the Handling of Organisms in the Environment

    Release Ordinance, RO

    Read the ordinance

  • Ordinance on Handling Organisms in Contained Systems

    Containment Ordinance, ContainO

    Read the ordinance

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