The International Law of Biotechnology
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The International Law of Biotechnology

Human Rights, Trade, Patents, Health and the Environment

Matthias Herdegen

Biotechnology is a field that inspires complex legal and ethical debates on an international scale. Taking a fresh approach to the subject, Matthias Herdegen provides a comprehensive assessment of the regulation of biotechnology processes and products from an international and comparative perspective.
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Chapter 3: Risks, perceptions and the law: regulatory approaches to risk

Matthias Herdegen


Different perceptions of risk can lead to different approaches to risk assessment and risk management. From a general perspective, a distinction can be drawn between two main regulatory approaches. First, the ‘product’ or ‘vertical’ approach, which centres on the features of a finalized biotech product. Second, the ‘process’ or ‘horizontal’ approach, which focuses on the production process rather than on the final product. These alternatives have played a fundamental role, for example, in the regulation of new methods of genetic engineering. Some international instruments additionally allow to take the socio-economic impact of some biotech products (e.g. living modified organisms) into account. Regulations are normally justified on objective, scientific criteria. However, scientific evidence does not always provide certainty about risks and thus leaves a corridor for policy choices. In international law, the precautionary principle covers restrictive measures in the face of potential risks which have not yet been established conclusively.

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