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Regulating Life Sciences
Last Updated: 2026-02-05 16:38:03
Abstract
Life sciences are subject to a complex regulatory framework, challenged by technological disruption, the globalized scale of business operations, personalized medicine, and ethical discussions in society. In these times of rapid changes, legal rules must steer innovation while balancing other societal goals, such as ensuring affordable medicines and addressing unmet medical need.
Objective
This course provides an in-depth introduction into the legal and policy regimes shaping pharmaceutical sciences, biotechnology, and medical devices. Topics encompass research and innovation, intellectual property, market entry, product liability, data protection, technology transfer, and competition in the life sciences industries. Governing regulations and their impact on innovation, commercialization, and access to new products and processes will be examined and debated. Current issues such as patent protection on HIV-drugs, TRIPS waiver on intellectual property related to COVID-19 vaccines and diagnostics, and regulatory failures in the opioid crisis will be the subject of further discussion.
Content
As an introductory course, the focus will lie on life sciences regulation in Switzerland. Selected examples ranging from bioinformatics, diagnostics, human genes, nanorobotic to stem cells and national cases studies from the European Union, the United States, and other countries will offer comparison and contrast. The course targets students from life sciences disciplines with an interest in law and policy. Understanding the rationale, advantages, and limitations of current regulatory approach in life sciences provides students with a sound basis for their career in academia, industry, or start-ups.
General Information
- Language
- English
- Levels
- DS
- Frequency
- Yearly recurring
Examination
- Type
- graded semester performance
Course Components
| Type | Title | Time & Place | Hours |
|---|---|---|---|
| lecture | Regulating Life Sciences |
|
2 h weekly |
Offered In
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Science in Perspective (In “Science in Perspective”-courses students learn to reflect on ETH’s STEM subjects from the perspective of humanities, political and social sciences. Only the courses listed below will be recognized as "Science in Perspective" courses.)
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Type A: Enhancement of Reflection Competence (SiP courses are recommended for bachelor students after their first-year examination and for all master- or doctoral students. All SiP courses are listed in Type A. Courses listed under Type B are only recommendations for enrollment for specific departments.)
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