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Matthias Herdegen

As trade in biotech products grows, restrictive sanitary and phytosanitary measures as well as restrictions aimed at the protection of public morals turn into a salient issue in international trade law. The WTO Agreement establishes strict standards for scientifically sound risk assessment and risk management, leaving a limited corridor for the application of the precautionary principle. By contrast, the Cartagena Protocol on Biosafety and EU Law provide a broad corridor for social and economic considerations, which might fuel new controversies, e.g. as to genetically-modified crops. The interaction of these standards triggered international disputes, such as EC-Biotech before the WTO Dispute Settlement Body. Ethical debates surrounding biotech products might additionally pose new challenges to the interpretation and application of the GATT general exceptions. Beyond the WTO, new regional trade agreements have included provisions specifically tailored to address biotech products.

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Matthias Herdegen

Biodiversity is the source of genetic resources capable of being used in industrial processes. While the exploitation of genetic recourses has been dominated by industrialized countries, the world’s most biodiverse regions correspond to developing or emerging economies. The Convention on Biological Diversity has sought to strike a balance between the ‘global north’ and the ‘global south’ in this sensitive area, seeking to counter the unfair appropriation of genetic resources. In this vein, it introduces mechanisms of access and benefit sharing (ABS). The Nagoya Protocol on Access and Benefit Sharing facilitates the implementation of these mechanisms. Further steps towards a fair use of genetic resources have been taken in the context of the FAO. The FAO Seed Treaty seeks to line the FAO regime for plant genetic resources with the Convention on Biological Diversity. In this context, the rights of indigenous peoples are an important concern which includes the protection of traditional indigenous knowledge.

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Matthias Herdegen

Patents on biotechnological inventions provide essential economic incentives to biotechnological research. In WTO law, the TRIPS Agreement governs patentability and compulsory licencing, a mechanism aimed at balancing the economic interests of patent holders with the need to grant broad access to particular kinds of patented products (e.g. pharmaceuticals). In the EU, Directive 98/44/EC establishes rules which specifically deal with biotechnological inventions. A particularly contentious issue are patents on living organisms. Other controversies relate to patents on DNA sequences, and the patentability of techniques based on indigenous knowledge. Applicable regulations generally recognize public policy or morality as reasons to deny a patent. Some famous disputes, such as the case Brüstle v Greenpeace before the ECJ, turn on the interpretation of these exceptions.

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Matthias Herdegen

Biotechnology poses significant challenges to States, international organisations and the international community at large. Differing risk perceptions and varying levels of risk aversion influence regulation of biotechnology. Normative, ethical and technical standards justify and limit regulatory decisions. In the long run, regulatory choices may affect consumers’ preferences. Still, the individual’s choices in favour or against biotech products are rooted on personal freedom and autonomy. In this subjective realm, preferences require no objective justification.

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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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Matthias Herdegen

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Matthias Herdegen

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Matthias Herdegen

Biotechnology significantly contributes to economic development as well as to the improvement of life quality. From an international and comparative perspective, biotechnological products and processes give rise to a broad range of regulatory issues which range from human rights to international trade law. Legal responses reflect intense scientific and ethical debates. Green biotechnology modernizes agricultural processes, increasing the quality of the products that reach consumers. Red biotechnology helps develop new vaccines and other pharmaceutical products. White biotechnology has transformed entire industries through the use of living organisms (e.g. bacterial enzymes or biomass) in industrial processes and energy production. Grey biotechnology fosters environmental protection and accelerates recovery of damaged ecosystems. Blue biotechnology improves the utilisation of marine resources.

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Matthias Herdegen

Biotechnology has given rise to a close interaction of legal and ethical arguments. Religious beliefs and cultural differences could lead to conflicting approaches to topics such as in vitro fertilisation or pre-implantation diagnostics. In a secular state, regulatory decisions must be based on secular arguments. Still, religious beliefs and prevailing societal concepts or opinions influence regulatory approaches as to the status of early human life, the relative weight of competing interests and real or phantom risks. International law often requires regulatory decisions to be consistent and proportional. Thus, domestic regulatory choices should be based on common standards of rationality. Empirical criteria avoid subjectivism but should not entirely pre-empt value judgments. Still, socio-culturally entrenched values could pose severe difficulties to the development of international standards of bioethics. When international tribunals and other adjudicatory bodies overstretch international standards through an activist interpretation of international treaties, they may unduly narrow the corridor for democratic decisions at the national level. The standard of consistency preserves some deference to democratic choices.

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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.